Primary responsibilities are to:
· Conduct risk assessment and develop mitigation strategies as they relate to QA, QC, and RA people, process, and systems including organizational assessments; such as change readiness and develop training strategy to address gaps and needs.
· Ensure regulatory and contractual compliance following applicable standards including FDA regulations, American Association of Tissue Banks (AATB) requirements, ISO 9001, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC) and other National and International regulations and standards.
· Provide leadership for preparation and execution of FDA inspections, AATB audits, ISO certification and customer audits by mentoring management representatives and verifying site readiness.
· Provide guidance in the development and implementation of quality documents including SOPs, test methods, specifications, donor records, stability protocols, validation protocols, and batch record documentation; and review and approve quality documents and agreements with critical suppliers and partners.
· Lead, participate, and mentor site personnel in investigations, complaints, CAPA, change control, auditing, document management systems, and process design and implementation.
· Lead and participate in Quality Assurance initiatives within cross-functional teams as a recognized expert and resource in one or more relevant non-project specific areas of expertise for the company.
· Demonstrate innovation in the project management and creation of deliverables and manage multiple projects simultaneously; work directly with other functional groups to ensure the inclusion of diverse, cross-functional perspectives into strategies and tactics that consistently enhance Quality Assurance's ability to deliver.
· Coordinate and execute audits to qualify new and existing suppliers/contract manufacturers.
· Develop and manage the QE programs for MVP execution, pFMEAs, risk management and statistical support to QA
· Work with Integra senior division Quality Assurance management to set up EMQA , tissue/product QA programs for full execution.
· Control and approve all changes to product /process specifications for products supplied by supplier/contract manufacturers.
· Establish and implement DHR review and final lot approval of product from supplier/contract manufacturers, including donor record reviews.
· Prepare and execute Quality Agreements for the daily interactions and sharing of responsibility between the QA departments at Integra and supplier/contract manufacturers.
· Design and execute Quality Plans for projects to commercial new products and for product transfers.
· Lead and chair EM change control, MRB and CAPA boards.
· Develop and report key metrics to manage and evaluate control of the supplier/contract manufacturer QA programs.
· Develop and present EMQA key metrics to division and corporate QMR, SMT and EMT.
· Establish procedures for the execution of the Quality Assurance program.
· Manage and track spending versus assigned budgets.
· Design and execute training programs for Integra QEs and supplier/contract manufacturers for the QA program.
· Education: B.S. degree in science or engineering Advanced degree in engineering, or RA preferred
Demonstrated knowledge of regulations including FDA 21 CFR 820, 1270 and 1271, AATB requirements, ISO 9001, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC) and other National and International regulations and standards.
· Certifications: Quality Engineering and/or Auditor certification. Lean Manufacturing and Six Sigma training desirable.
· Experience: 12-15 years experience in the FDA regulated industry preferably medical devices and tissue technologies with extensive knowledge of cGMPs, and medical device regulations.
· Experience with direct contact with FDA, EMA, Health Canada, KFDA, ROW health authorities/Global Competent Authorities, and ISO Notified Bodies.
· Computer skills, communication capability, interpersonal skill sets, ability to multi-task in fast paced environment, etc}.