Job Description
Pride Health is hiring a Staff Quality Engineer to support our medical client in Marlborough MA 01752 this is a 1 Year assignment with the possibility of a contract-to-hire opportunity, and it's a great way to start working with a top-tier healthcare organization!
Job Title: Staff Quality Engineer
Location: Marlborough MA 01752
Duration: 1 Year
Pay Range: $65 Per Hour - $70 Per Hour
Schedule: Monday Friday 8Am - 5Pm (Hybrid 3-4 Days Onsite)
Key Responsibilities:
Responsibilities:
Lead and maintain quality systems compliant with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IVDR
Drive design control and risk management activities across the IVD product lifecycle
Review and approve design inputs/outputs, V&V documentation, and risk management files
Lead internal and external audits, CAPA, nonconformance investigations, and supplier qualification
Support regulatory submissions, complaints handling, and post-market surveillance activities
Collaborate cross-functionally to embed quality and regulatory requirements into product development
Analyze quality metrics and drive continuous improvement initiatives
Qualifications:
Bachelor’s degree required
8+ years’ experience in medical devices/IVD with strong design control and risk management expertise
Deep knowledge of FDA, ISO, and IVDR requirements
Strong communication, problem-solving, and leadership skills
ASQ and/or RAC certification preferred
Pride Global offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance, and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance, and employee discounts with preferred vendors.
About Pride Health
Pride Health is Pride Global's healthcare staffing branch, providing recruitment solutions for healthcare professionals and the industry at large since 2010.
As a minority-owned business that delivers exceptional service to its clients and candidates by capitalizing on diverse recruiting, account management, and staffing backgrounds, Pride Health's expert team provides tailored and swift sourcing solutions to help connect healthcare talent with their dream jobs. Our personalized approach within the industry shines through as we continue cultivating honest and open relationships with our network of healthcare professionals, creating an unparalleled environment of trust and loyalty.
Equal Employment Opportunity Statement
As a certified minority-owned business, Pride Global and its affiliates - including Russell Tobin, Pride Health, and Pride Now - are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.