Validation Engineer

Quality Assurance Manager

Responsibilities:

• Establish quality systems/policies related to OOS, Deviations, CAPAs, NCMRs, and Complaints and work with various departments to ensure timely closure of related investigations. Document deficiencies, including root cause, corrective and preventive action plans. Ensure action plans are implemented in a timely manner.
• Support from a quality perspective, analytical test method qualification plans/protocols and reports.
• Assist with risk analysis activities and maintaining up to date risk management documents.
• Establish Quality Inspection Plans for the release of components, assemblies, and finished devices. Conduct quality inspections as needed.
• Support Manufacturing and R&D/Product Development, Analytical Development and Quality Control with statistical techniques, including design of experiments (DOE); sampling plans and data/ results analysis.
• Utilize statistical techniques, including design of experiments (DOE) and sampling plans to analyze results effectively.
• Support quality management programs such as supplier selection and certification. Perform supplier evaluations as needed to assure supplier capabilities including the assessment of the adequacy of inspection methods, manufacturing practices, and control and quality procedures to deliver conforming products in a timely manner.
• Lead supplier audits and works with suppliers to resolve audit findings and/or nonconformances.
• Perform internal audits as needed.
• Responsible for quality engineering review of Document Change Orders.
• Review specifications for products or processes.
• Set requirements for raw material or intermediate products for suppliers and monitor their compliance.
• Ensure adherence to regulatory requirements, and health and safety guidelines.
• Supervise inspectors, technicians and other staff and provide guidance and feedback.
• Quality oversight on all product development procedures to identify deviations from quality standards.
• Quality oversight on all product manufacturing processes and systems
• Quality oversight on all manufacturing output and ability to compare properties to requirements.
• Quality oversight on the sterilization and product release processes.

Qualifications:

• Minimum of a BS in Biomedical Engineering, Chemical Engineering, Biochemistry, Chemistry or equivalent degree.
• 5+ years relevant experience in medical devices. Experience in Biologics/Pharmaceutics or combination products is a plus.
• Must have a complete understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, and ISO 14971
• Experience in Biologics/Pharmaceutics or combination regulatory requirements, 21 CFR 211 and ICH Quality Guidelines is a plus.
• Highly motivated and self-directed with a strong sense of urgency, with an ability to pull in resources from other departments as required.
• Must be able to interface well with Management, Manufacturing and R&D/Product Development, Analytical Development and Quality Control.
• Ability to deliver, meet deadlines and be results oriented.
• Detail-oriented, thorough, observant.
• Excellent Communications Skills (oral, written, presentation) at different organizational levels.
• Experience with statistical techniques and tools.
• Experience with root cause analysis tools and methods.
• Certification(s) in quality engineering (e.g., ASQ Certified Quality Engineer) is a plus.