The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Visa sponsorship not available.

Our client is seeking a Senior Quality Assurance Specialist in Boston.

Skills & Requirements

Bachelor's degree in life science-related discipline or engineering CQM/CQE Courses preferred
At least 7 years of experience in similar positions, preferably in the medical device industry including ISO 13485, FDA QSR and EU AIMDD /MDR
Previous experience in external and internal audits, certified as an internal auditor and lead auditor
5 years QMS experience including: Design Control, Risk Management, CAPA, Document Control, Training, KPIs, Customer complaints
Capable of self-learning of applicable medical background
Languages: fluent in English

Responsibilities:

Supporting Design Control / PDP Process as Quality Lead
Approval of qualification and validation activities
Quality Lead on Risk Management activities
Prepare, implement and maintain quality procedures to ensure QMS in compliance with FDA-QSR, AIMD/MDR & ISO13485
Applying risk-based approach in QMS processes
Training and qualifying the company employees
Document Control management and retention
Customer complaints handling
CAPA process handling
Support external audits
Assess the quality procedure effectiveness by planning and conducting Internal Quality Audits
Prepare inputs for management review including quality data analysis / trends
Maintaining the quality system
Support improvement process
Create and realize quality plans

Benefits/Other Compensation:

Medical, Dental, Life Insurance, 401K.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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