{"jobs":[{"absolute_url":"https://www.accessvascularinc.com/careers?gh_jid=5990690004","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5151804004,"location":{"name":"Billerica, MA"},"metadata":null,"id":5990690004,"updated_at":"2026-05-07T12:42:05-04:00","requisition_id":null,"title":"Operator - Medical Device ","company_name":"Access Vascular","first_published":"2026-05-07T12:42:05-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div id=\u0026quot;block-yui_3_17_2_1_1604341215757_6441\u0026quot; class=\u0026quot;sqs-block html-block sqs-block-html\u0026quot; data-block-type=\u0026quot;2\u0026quot;\u0026gt;\n\u0026lt;div class=\u0026quot;sqs-block-content\u0026quot;\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;Access Vascular, Inc seeks an operator to add to their quickly growing team. The right candidate will be responsible for the detailed assembly and production of high-quality medical devices within manufacturing. This position includes comprehensive assembly and operation of various equipment and machinery.\u0026lt;/p\u0026gt;\n\u0026lt;h3\u0026gt;DUTIES AND RESPONSIBILITIES\u0026lt;/h3\u0026gt;\n\u0026lt;ul data-rte-list=\u0026quot;default\u0026quot;\u0026gt;\n\u0026lt;li\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;Manufacture, inspect and package products following written processes.\u0026lt;/p\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;Work at a pace that meets established time standards while making quality product.\u0026lt;/p\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;Identify quality issues or workmanship deficiencies related to equipment, assembly and inspection processes, materials, and manufacturing environment.\u0026lt;/p\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;Comply with cGMP requirements by maintaining individual training records and adhering to documented manufacturing practices and procedures as defined in quality systems procedures.\u0026lt;/p\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;Maintain a clean, safe and organized work environment.\u0026lt;/p\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;Comply with all policies and procedures.\u0026lt;/p\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;Perform other duties as assigned.\u0026lt;/p\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;h3\u0026gt;QUALIFICATIONS\u0026lt;/h3\u0026gt;\n\u0026lt;ul data-rte-list=\u0026quot;default\u0026quot;\u0026gt;\n\u0026lt;li\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;High School Diploma or equivalent required.\u0026lt;/p\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;Prior experience in a medical device manufacturing setting is required.\u0026lt;/p\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Embody the AVI Guiding Principles to each job Qualifications\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;Ability to read and understand policies, procedures and processes written in English.\u0026lt;/p\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;Good hand-eye coordination, attention to detail, effective communication skills.\u0026lt;/p\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;Demonstrated ability to achieve quality and labor time targets required.\u0026lt;/p\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;h3\u0026gt;\u0026lt;strong\u0026gt;PHYSICAL DEMANDS\u0026lt;/strong\u0026gt;\u0026lt;/h3\u0026gt;\n\u0026lt;p class=\u0026quot;\u0026quot;\u0026gt;The physical activities described within the job posting are representative of those that must be met by an employee to successfully perform the essential functions of this job.\u0026lt;/p\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;div id=\u0026quot;block-yui_3_17_2_1_1604341215757_6032\u0026quot; class=\u0026quot;sqs-block horizontalrule-block sqs-block-horizontalrule\u0026quot; data-block-type=\u0026quot;47\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Access Vascular, Inc is a proud Equal Opportunity/Affirmative Action Employer. All\u0026amp;nbsp;qualified applicants will receive consideration for employment without regard to\u0026amp;nbsp;race, color, religion, sex, sexual orientation, gender identity, national\u0026amp;nbsp;origin, age, protected veteran status or disability status.\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Hourly Rate\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$21\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$24 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;h1\u0026gt;About Access Vascular\u0026lt;/h1\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;a href=\u0026quot;https://www.accessvascularinc.com/\u0026quot;\u0026gt;Access Vascular\u0026lt;/a\u0026gt; was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4001614004,"name":"Operations","child_ids":[],"parent_id":null}],"offices":[{"id":4032852004,"name":"Access Vascular","location":"Billerica, MA","child_ids":[],"parent_id":null}]},{"absolute_url":"https://www.accessvascularinc.com/careers?gh_jid=5803245004","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_optional","internal_job_id":5051653004,"location":{"name":"Billerica, MA"},"metadata":null,"id":5803245004,"updated_at":"2026-02-18T13:10:53-05:00","requisition_id":null,"title":"Senior Designs Assurance Quality Engineer","company_name":"Access Vascular","first_published":"2026-02-12T16:42:55-05:00","language":"en","application_deadline":null,"content":"\u0026lt;table style=\u0026quot;height: 1498.62px;\u0026quot; width=\u0026quot;684\u0026quot;\u0026gt;\n\u0026lt;tbody\u0026gt;\n\u0026lt;tr style=\u0026quot;height: 198.75px;\u0026quot;\u0026gt;\n\u0026lt;td style=\u0026quot;width: 105.188px; height: 198.75px;\u0026quot; width=\u0026quot;162\u0026quot;\u0026gt;\n\u0026lt;p\u0026gt;Job Description\u0026lt;/p\u0026gt;\n\u0026lt;/td\u0026gt;\n\u0026lt;td style=\u0026quot;width: 551.229px; height: 198.75px;\u0026quot; width=\u0026quot;522\u0026quot;\u0026gt;\n\u0026lt;p\u0026gt;Manage the Design Control and product design and change Risk Management processes for sterile catheter-, software-, electromechanical-based medical device product families.\u0026amp;nbsp; \u0026amp;nbsp;Provide Quality Engineering support for Product Development Projects throughout all phases of Design Controls (Concept to Launch) and Design Risk Management.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This is a key contributor position working closely with R\u0026amp;amp;D, Operations, Commercial, Regulatory and Operations Quality to ensure compliance with AVI’s QMS and FDA QMSR requirements, with particular focus on Design Controls and Risk Management.\u0026lt;/p\u0026gt;\n\u0026lt;/td\u0026gt;\n\u0026lt;/tr\u0026gt;\n\u0026lt;tr style=\u0026quot;height: 590.656px;\u0026quot;\u0026gt;\n\u0026lt;td style=\u0026quot;width: 105.188px; height: 590.656px;\u0026quot; width=\u0026quot;162\u0026quot;\u0026gt;\n\u0026lt;p\u0026gt;Duties \u0026amp;amp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Responsibilities\u0026lt;/p\u0026gt;\n\u0026lt;/td\u0026gt;\n\u0026lt;td style=\u0026quot;width: 551.229px; height: 590.656px;\u0026quot; width=\u0026quot;522\u0026quot;\u0026gt;\n\u0026lt;p\u0026gt;· Responsible for overall Design Quality process to ensure that company design control projects comply with internal design control and risk management procedures in accordance with FDA, ISO and other applicable requirements\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Lead cross functional teams to implement and periodically review hazard analyses, risk evaluation, assessment and other risk management processes\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Provide guidance to project team members to ensure that design control requirements are being met in an effective manner in order to achieve quality by design\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Support development, implementation and maintenance of Design Verification \u0026amp;amp; Validation methodologies and best practices to impact product quality and launch timeliness\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Collaborate with Operations and Operations Quality to ensure effective and successful design transfer to manufacturing\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Drive quality focused design and development of device software by defining the requirements, design, verification and validation plan and strategies while maintaining traceability and compliance to IEC 62304 and FDA guidance documents related to medical device software\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Act as a subject matter expert for Quality Engineering practices, such as statistical analysis, failure investigations, hazard identification and risk analysis, and quality data trending and analysis\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending\u0026lt;/p\u0026gt;\n\u0026lt;/td\u0026gt;\n\u0026lt;/tr\u0026gt;\n\u0026lt;tr style=\u0026quot;height: 709.219px;\u0026quot;\u0026gt;\n\u0026lt;td style=\u0026quot;width: 105.188px; height: 709.219px;\u0026quot; width=\u0026quot;162\u0026quot;\u0026gt;\n\u0026lt;p\u0026gt;Qualifications\u0026lt;/p\u0026gt;\n\u0026lt;/td\u0026gt;\n\u0026lt;td style=\u0026quot;width: 551.229px; height: 709.219px;\u0026quot; width=\u0026quot;522\u0026quot;\u0026gt;\n\u0026lt;p\u0026gt;· BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· 5-8 years of design assurance experience in medical device design and manufacturing environment\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Proven track record of completing new product introduction transfers to Operations\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Working knowledge of Medical Device Regulation FDA 21 CFR 820 and ISO 14971, 13485, ISO 10993, IEC 60601 and IEC 62304 series of standards, other applicable regulations and industry standards pertaining to the design of medical devices\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Experience with preparing and reviewing design documentation in support of regulatory submissions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Working knowledge of data analysis methods, including basic statistics, preferably using Minitab or other similar data analysis software\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Working knowledge with various quality tools such as Failure Mode and Effects Analysis (FMEA) and Use Related Risk Analysis (URRA), Statistical Process Control (SPC), Root Cause Analysis (RCA), Measurement Systems Analysis (MSA) \u0026amp;amp; Gage Repeatability and Reproducibility (Gage R\u0026amp;amp;R)\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Experience with manufacturing complex medical devices, including process validation and equipment qualification requirements (IQ/OQ/PQ).\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Experience managing third-party development and test organizations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Ability to communicate ideas and information clearly, effectively, and concisely\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;· Possess the following key traits: teamwork, flexibility and adaptability to change, critical reasoning and excellent data presentation skills, excellent written and verbal communication and skills\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The ideal candidate must have a foundation in being a self-starter with strong organization skills.\u0026lt;/p\u0026gt;\n\u0026lt;/td\u0026gt;\n\u0026lt;/tr\u0026gt;\n\u0026lt;/tbody\u0026gt;\n\u0026lt;/table\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Compensation Commensurate With Experience\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$135,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$160,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;h1\u0026gt;About Access Vascular\u0026lt;/h1\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;a href=\u0026quot;https://www.accessvascularinc.com/\u0026quot;\u0026gt;Access Vascular\u0026lt;/a\u0026gt; was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4001615004,"name":"Quality","child_ids":[],"parent_id":null}],"offices":[{"id":4032852004,"name":"Access Vascular","location":"Billerica, MA","child_ids":[],"parent_id":null}]},{"absolute_url":"https://www.accessvascularinc.com/careers?gh_jid=6002805004","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5157219004,"location":{"name":"Billerica, MA"},"metadata":null,"id":6002805004,"updated_at":"2026-05-26T09:37:25-04:00","requisition_id":null,"title":"Senior Quality Systems Engineer","company_name":"Access Vascular","first_published":"2026-05-26T09:37:25-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Descriptions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Manage the Access Vascular Inc (AVI) Quality Management System for a growing start-up company that designs, manufactures, and distributes sterile catheter-, software-, electromechanical-based medical device product families. Provide Quality Engineering support for Operations and Operations Quality projects and tasks.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This is a key contributor position working closely among the AVI team with AVI’s QMS and FDA QMSR requirements.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Quality Management System\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;• \u0026amp;nbsp; \u0026lt;/strong\u0026gt;\u0026amp;nbsp;Own, maintain, and continuously improve the company\u0026#39;s QMSR and ISO 13485-compliant QMS\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Drive continuous improvement to company SOPs, work instructions, forms, test protocols, infrastructure software and other controlled documents\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Manage document control and records management in compliance with 21 CFR Part 820\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead internal audits and support external audits (FDA, Supplier)\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead CAPA investigations to root cause, ensuring timely closure and effectiveness verification\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Develop and communicate quality metrics and data analysis to inform continuous improvement and risk-based decision making\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead statistical methods development for quality metrics, inspection planning, and continuous improvement initiatives\u0026lt;strong\u0026gt;\u0026lt;br\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Operations \u0026amp;amp; Supplier Quality\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate with Operations to ensure manufacturing processes are controlled and validated\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Act a subject matter expert (SME) for risk management, sterilization validation, and data integrity and how it defines validation, verification, and inspection sampling rigor\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support incoming inspection, nonconforming material control, and disposition activities\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide Quality Engineering support to infrastructure move and expansion projects\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Manage supplier qualification, evaluation, and monitoring programs\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Conduct supplier audits and review supplier corrective action responses\u0026lt;strong\u0026gt;\u0026lt;br\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Post-Market Surveillance\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Manage complaint handling, MDR reporting processes, and trend analysis\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Maintain knowledge of applicable standards and regulations and communicate updates to the team\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Assist in preparation for and response to FDA inspections and Notified Body audits\u0026lt;strong\u0026gt;\u0026lt;br\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Leadership \u0026amp;amp; Culture\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Champion a proactive quality culture across a small, multidisciplinary team\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide quality training and mentoring to engineering, operations, and management staff\u0026lt;strong\u0026gt;\u0026lt;br\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Bachelor\u0026#39;s degree in Engineering, Life Sciences, or a related technical field\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Minimum of 5 years’ of quality systems experience with a medical device manufacturing company\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proven track record with implementing, evolving, and improving medical device company quality management systems (QMS) compliant to FDA 21 CFR Part 820, ISO 13485:2016, and ISO 14971\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Demonstrated experience owning a QMS end-to-end, including CAPA, document control, complaints, internal auditing, and supplier quality\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strong technical writing skills with the ability to produce clear, compliant documentation\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience with statistical techniques, sampling plans, and data analysis for validation and process capability\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Highly organized, self-directed, and comfortable in a fast-paced environment\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;ASQ Certified Quality Engineer (CQE), Certified Medical Device Auditor (CMDA), or equivalent is a plus\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead auditor certification (ISO 13485 or equivalent) is a plus\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience with implementing and validating eQMS platforms (e.g., Greenlight Guru, MasterControl, ETQ) is a plus\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Familiarity with IEC 62304 (software lifecycle) and IEC 60601 (electrical safety) is a plus\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience supporting 510(k) submissions or technical files for CE marking is a plus\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Prior experience at a startup or early-stage medical device company is a plus\u0026lt;strong\u0026gt;\u0026lt;br\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Compensation Commensurate With Experience\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$93,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$160,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;h1\u0026gt;About Access Vascular\u0026lt;/h1\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;a href=\u0026quot;https://www.accessvascularinc.com/\u0026quot;\u0026gt;Access Vascular\u0026lt;/a\u0026gt; was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4001615004,"name":"Quality","child_ids":[],"parent_id":null}],"offices":[{"id":4032852004,"name":"Access Vascular","location":"Billerica, MA","child_ids":[],"parent_id":null}]}],"meta":{"total":3}}