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Senior QA Engineer (Risk Management)

Location: Marlborough , Massachusetts

Connexion Systems and Engineering, your Boston staffing experts, would like to provide you with details about this new opportunity as we are seeking individuals with the following skills:


Senior QA Engineer -Risk Management

Essential Duties and Responsibilities

  • Participates in ensuring that the implementation, effectiveness and integrity of quality system is compliant to all applicable standards and regulations.
  • Supports the timely implementation of In Vitro Diagnostic Regulation (IVDR) risk documents. These documents need to be remediated, or created according to the program implementation schedule.
  • Responsible for gathering documentation related to our Risk Management Files, reviewing risk documents for compliance, and remediating/recreating risk documentation as necessary.
  • Responsible for updating and/or creating new dFMEAs and pFMEAs from scratch, writing Risk Plans, Risk Reports, Performance Evaluation Report Statements, and Post Market Surveillance Report Conclusion Statements.
  • Work with R&D and Manufacturing groups on FMEA Remediation, as well as with Post Market Surveillance and Clinical Affairs groups to assess Overall Residual Risk and Risk-Benefit analysis as needed.
  • Develops quality plans for Quality System updates to changing regulations and standards.
  • Develops process flowcharts for use in creating Quality System procedures and processes.
  • Develops and implements procedures, forms and/or templates to assure compliance with Quality System Regulation, EU Medical Device Regulation and ISO 13485:2016 as well as other International regulatory requirements.
  • Provides training on quality system requirements, as necessary
  • Complies with all Quality System procedures.
  • Other duties as required


  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Computer literate: able to use word processing and spreadsheet programs.
  • Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
  • Excellent written, verbal and presentation skills.
  • Excellent interpersonal skills to interact with all levels of the company and oversight agencies, sometimes in an adversary role.

• Bachelor’s degree or equivalent combination of education and experience. 


  • Seven to ten years related experience in an FDA regulated industry with at least five years recent experience in Medical Devices or equivalent combination of education and experience.

Specialized Knowledge

  • Excellent working knowledge of medical device regulations (21CFR), ISO 13485, Medical Device Directive, EU Medical Device Regulation (in particular)
  • This individual must be comfortable in a hands-on role, with strong experience in Risk Management (ISO 14971:2012), 21 CFR Part 820, Design Controls, Risk Controls, dFMEA & pFMEA review / remediation / creation, Risk Classifications, Post-Market Risk Management, Clinical Risk-Benefit Analysis, Root Cause Analysis, and Change Control/Design Changes.
  • Certified Quality Auditor/Certified Lead Auditor desirable
  • Familiarity with the corrective action and internal audit processes related to the medical device industry
  • Experience with Agile Product Lifecycle Management system a plus
  • This individual must be comfortable in a hands-on role, with strong experience in Risk Management (ISO 14971:2012), 21 CFR Part 820, Design Controls, Risk Controls, dFMEA & pFMEA review/remediation/creation, Risk Classifications, Post-Market Risk Management, Clinical Risk-Benefit Analysis, Root Cause Analysis, and Change Control/Design Changes.
  • EU IVDR or EU MDR project-experience would be a plus

Additional Details 

  • Must be able to use hands and be mobile to get around production floor, engineering labs, warehouse and dock areas
  • Vision abilities required include: close vision, distance vision, color vision, depth perception and ability to adjust focus
  • Must be able to work independently and make decisions based on data and objective evidences


Date Posted: 6/10/2019

Hiring Organization: Connexion Systems & Engineering

Job Title: Senior Quality Assurance Engineer – Risk Management

Industry: IT

Location: Marlboro, MA 01752

Employment Type: Full Time, Contract

Pay Range:  50-60/hr.

Duration: 1 Year

Job #: bh10063


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ConneXion Systems & Engineering

490 Boston Post Road

Sudbury, MA 01776