Quality Assurance Manager, Biopharma (JP10285)
3 Key ConsultingThousand Oaks, California, United States
Posted May 20, 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
We are hiring a Quality Assurance Manager for a consulting engagement with a leading global biopharmaceutical company. The role involves providing quality oversight for the development and lifecycle management of test and inspection methods, and fulfilling regulatory commitments.
Requirements
- BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries
- 8 years current experience with engineering processes/procedures and quality tools
- Major contributions to or the leadership of projects from development through the 510k and PMA approval process
- 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 in test or inspection method design and development
- Small scale device assembly and/or benchtop testing experience
- Experience with Automated Test Equipment (ATE)
- Experience with regard to Measurement Systems Analysis/GRR principles, including study design/execution/troubleshooting
- Strong critical thinking, problem solving, risk assessment, and risk management skills