You will primarily be responsible for conducting audits of practices at suppliers manufacturing plants and sites to ensure compliance to our client’s, ISO 13485 standards and FDA regulations.
Duties/Responsibilities
• Conduct Quality System Site Audits of existing or new Suppliers
• Develop and implement Supplier quality evaluation systems. Including continuous quality assessment and monitoring
• Manage supplier performance metrics (Scorecard). For suppliers that do not meet required levels, issuing Supplier Corrective Action Reports (SCAR) or other performance improvement initiatives and ensure these are being completed as planned.
• Develop & implement plans to improve performance of business critical suppliers, which may include leading efforts to resolve recurring supply chain issues involving quality & delivery
• Conduct and confirm follow up actions from supplier quality system audits
• Responsible for Early Supplier Involvement. Coordinate with Engineering and Supply Chain Management to engage suppliers in design/process improvements in the concept phase of product development
• Participate in New Product Development teams for qualifying new supply sources; this encompasses raw materials, components, sub-assemblies, assemblies, and service suppliers
• Train other members of staff on QA specifications for suppliers
• Lead teams in new supplier qualifications when need has been identified (i.e., outsourcing opportunities, low cost country sourcing, existing supplier replacement).

Qualifications
• Bachelor’s degree in Engineering , Quality Assurance , or equivalent technical education required
• 5+ years experience in manufacturing / quality with a working knowledge of inspections techniques and procedures
• Experience of working within the Medical Devices industry in a manufacturing environment.
• Experience of working to ISO 13485 standards and conducting supplier audits
• Flexibility to travel to supplier sites
• Working knowledge of validations (IQ, OQ, PQ), process FMEA and failure analysis diagnosis
• Able to analyze & present fact based management reporting with recommendations
• Working knowledge of statistical tools (control charts, SPC, probability, and trending)
• Strong math and computer skills along with interpersonal, teamwork, decision making, problem solving, and root cause analysis and written skills (technical writing and presentation)
• Working knowledge of applicable Code of Federal Regulations (21 CFR Parts 7, 11, 803, 806, 820, etc.) and ISO 13485 systems
• ASQ certified Quality Engineer, (CQE) Certified Auditor Credentials, Six Sigma certified and knowledge of Lean Manufacturing principles desired.
• Detailed understanding of international quality systems (ISO, cGMP, CE, etc.).