Senior Quality Management Systems Specialist / Engineer
About the Position:
- Title: Sr. Quality Management Systems Engineer
- Growth potential: Manager of Quality
- Location: Central MA
- Compensation: TBD based in experience and fit
- Reports to: Director of Quality & Regulatory
- Reason open: company growth
Overview:
- Maintain, improve, and ensure compliance of the QMS in accordance with ISO 9001, ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements. Support continuous improvement initiatives, internal and customer audits, CAPA processes, and documentation control.
- Develop and maintain QMS documentation including SOPs, work instructions, and related forms and specifications.
- Train employees to the QMS documentation.
- Position is on-site. No remote. Possible work from home in time.
- No Visa sponsorship
About my Client:
For over 40 years, my client has been a leader in the design and development of components and products for medical and industrial applications.
Required Skills & Experience:
- 6+ years of Medical Device industry experience developing, maintaining and improving Quality Systems.
Recommended Jobs
Front Desk East Boston
B/SPOKE FRONT DESK APPLICATION: At B/SPOKE, we believe fitness should be inspiring, rewarding, and complementary to all the rest of life's pursuits. For many of us, it's a form of therapy – a wa…
Hospitalist Physician
We are seeking a full-time Board-Certified or Board-Eligible Internal Medicine or Family Medicine Hospitalist to join our established hospitalist team in Lawrence, Massachusetts. This role is based at…
Emerging Store Manager
Supervises customer service associates and designated hitters. Responsible for managing front end of the store and making recommendations on the overall operations of the Pharmacy and Retail Store. …
Quality Assurance Engineer
Emerging from MIT, Poly6 is an exciting, innovative manufacturing company that specializes in the development and production of advanced additive manufacturing and ceramic components for aerospace tur…
Clinical Diabetes Specialist - Boston, MA
About Beta Bionics Beta Bionics, Inc. is a medical technology company dedicated to bringing innovative type 1 diabetes management solutions to the many, not the few. We are committed to bringing b…
Host
$15 per hour - $18.75 per hour Our Winning Family Starts With You! Check out these great benefits! ~ Flexible schedules to help you balance other life commitments (school, childcare, fami…
Program Manager, Global New Product Launch and Rollout
JOB DESCRIPTION Job Title Program Manager, Global New Product Launch and Rollout Job Description We’re seeking a Program Manager to join our Clinical Informatics team to lead market‑f…
Consultant, Customer Solutions
Ideal candidates will be based in Boston, MA. This position will require candidates to work onsite at a customer location in Boston, MA. The schedule will be onsite Monday through Thursday during sta…
Home Services Manager (Needham, MA)
Who We Are Hassle Free Home Services was born out of a realization that homeownership came with its share of surprises – a never-ending to-do list, constant maintenance, and unexpected upgrades. S…
Director/Senior Director of Development, Athletics
The UMA Foundation, a leading non-profit organization dedicated to the advancement of ultrasound medicine, is seeking a dynamic and experienced Director/Senior Director of Development to lead our fund…