Senior Quality Assurance Engineer

Sterling-Hoffman Executive Search Located in: Massachusetts
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Our client, a leading medical device company, is currently seeking an accomplished Senior Quality Assurance Engineer to join the team. Here is an overview of the role:

1) Develop, implement and improve process effectiveness and efficiency
2) Work closely with the Product Development and Product Transfer teams
3) Guide in ensuring product is properly transferred to production or new manufacturing locations
4) Maintain compliance with government regulations and industry standards
5) Ensure design change control effectiveness and compliance
6) Develop and implement product and process verification and validation plans
7) Evaluate and support product design and transfer milestones and deliverables
8) Identify and mitigate compliance risks by assisting Engineering, Manufacturing, Quality and Compliance representatives
9) Communicate audit results and recommend them to the Senior Management
10) Create and drive business wide improvement efforts to improve systemic challenges
11) Interface with superiors and partners during inspections, audits and investigations
12) Ensure adoption of QMS practices by training and educating Engineering, Manufacturing, Quality and Compliance representatives
13) Develop and implement useful and compliant solution for product or process corrections
14) Demonstrate action plans and CAPA programs
15) Assist with processing issues and assessing potential difficult impacts to finished product


  • 1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the medical device industry is strongly preferred
    4) Preference will be given to candidates with recent experience in quality assurance engineering

    This role is a great opportunity for the right person looking to advance their career with a wonderful company. If you are qualified and think that you are a strong fit for this role, please apply ASAP!


Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs


Seniority Level:
Experienced - Not Management
Preferred Industry Background:
Managing a team of:
Required Travel:

Base Salary:
Other Compensation: