Quality Assurance Manager, Biopharma (JP10327)
3 Key ConsultingCambridge, Massachusetts, United States
Posted May 26, 2022
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Full Time
About the Company
3 Key Consulting is a specialized staffing and consulting firm with 12 years of experience placing business and IT professionals in the life sciences and healthcare sectors. Leveraging a broad network of industry experts and partnerships with leading academic institutions, the firm offers a full suite of talent acquisition services—including PEO, compliance, and niche domain staffing in biomedical, pharma, medical devices, and business intelligence. Its core focus on people, process, and technology enables faster, cost‑effective solutions that improve workforce productivity and market efficiencies. 3 Key’s collaborative culture and commitment to delivering better, faster, and more efficient staffing and consulting services distinguish it as a trusted partner for organizations seeking high‑quality talent and operational excellence.
Job Description
Quality Assurance Manager for a consulting engagement with a leading global biopharmaceutical company. Responsibilities include providing quality oversight, leading and/or supporting technical teams, and ensuring compliance to design controls and regulatory commitments.
Requirements
- BS or BE in Engineering
- 8 years current experience with engineering processes/procedures and quality tools
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA
- Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions
- Experience with Automated Test Equipment (ATE) and Measurement Systems Analysis/GRR principles
- Strong critical thinking, problem solving, risk assessment, and risk management skills
Benefits
- Paid time off
- Health insurance
- Retirement plan
- Professional development opportunities
