Manager Product Assurance

* Ensures site audit readiness; prepares Quality Management System reviews
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Has authority to stop production, issue product holds (stop orders), release products and sign off on project milestones
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Maintains oversight of the complaints and daily processes to ensure issues are being addressed in a timely and thorough manner and conform to complaint policy and procedures
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Technical expertise will revolve around the knowledge of FDA's GMP regulations (QSR 820 and 210/211) and ISO13485
* Implement product/process validation requirements with R&D and Manufacturing groups (pilot and scale-up to commercial volume)
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Lead the MRB activities and contribute to closing of NMRs/Deviations/CAPAs
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Conduct internal audits to ISO13485 and FDA's QSR/QSIT processes. Manage and contribute to closure of internal and external audit findings
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Create document ownership/training program for SOP, MPI, WI level documents. Work with and train Engineers on FDA and ISO13485 regulations
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Interface with suppliers, partners, contract manufacturers on a regular basis, including supplier and contract manufacturer qualification, audit suppliers. Manage Supplier Corrective Action Required process
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Responsibilities at multiple sites (within 15 miles in the Bay Area)
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regulations, safety standards and regulatory compliance guidelines.
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Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
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Demonstrated expertise around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement
* Strong experience in technical support and complaint handling, reporting and Requires strong written
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Plans, organizes, and prioritizes own work routine to meet established schedule and support the activities of Product Assurance.
* ASQ certifications for CQE, CQA, or equivalent highly recommended.
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Technical writing proficiency (e.g., protocols, analytical reports, DCOs, SOPs, Test Methods, procedures)
* Integrity: Accepting & adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with others
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6-8 years of related work experience in a regulated industry. Clinical experience a plus.

To find out more about Real Staffing please visit www.realstaffing.com