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.
- 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
- 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
Location: Marlboro, MA 01752
Employment Type: Full Time, Contract
Pay Range: 50-60/hr.
Duration: 1 Year
Job #: bh10063
When responding to this job posting you MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to email@example.com. We would be glad to help you find the perfect job!
ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776