Provides overall quality assurance leadership in the management and qualification of suppliers and/or external manufacturers (EMs). Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance metrics of both the supplier quality systems and suppliers are continually measured to drive improvement initiatives. This position aids in the identification and eliminate supply chain risks via internal and supplier partnerships. Leads/participates in supplier/EM engagements to assess technical competency and general compliance to requirements, i.e., material specifications, CTQ’s, process control plans, quality agreements, etc. Key areas of focus within supplier management are performance monitoring/reporting, compliance to client standards and stream line processes. Key areas of support provided to team members include; risk management/communication, defect resolution, process capability/process improvement, and quality assurance general support.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES
• Performs quality processes including; change control, supplier non-conformance, quality agreements. Participate in local site supplier/EM quality meetings to ensure communication and alignment of quality initiatives. Lead supplier/EM quality evaluations. Provide third party inspection support.
• Lead defect resolution, root cause investigation, and continuous improvement activities. Collaborate across functions to confirm if non-conformances are supplier/EM related as applicable.
• Support internal and/or external cross-functional and cross sector project teams driving supplier/EM improvement and general initiatives through reducing variations in supply chain, institute control plans, and improving process capability. Provide Quality Engineering support to suppliers/EMs including verification/validation activities. Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault Three Analysis (FTA), Root Cause Analysis, Design of Experiment (DOE) etc., to the development of new products or processes related to raw materials, services, and finished products.
• Maintain, support compliance of, and improve supplier/EM quality processes, including procedural and electronic systems. Support alignment with enterprise standards and executing gap assessments. Provide regulatory guidance and interpretation to internal and external partners with regards to the following areas: EM and Supplier Quality procedures, medical devices, and combination products.
• Accountable, as applicable for compliance in accordance with regulations such as and from, but not limited to, FDA Quality System Regulation, ISO 13485, EU MD Directive/Regulations, FDA, 21 CFR 820; FDA Combo Product Regulation 21 CFR Parts 4 with 21 CFR 210/211, Japanese MHLW, Health Canada, Brazilian ANVISA, Australian TGA for the company's products including medical devices and combination products.
• Evaluate processes to determine if refinements would enhance speed of results and productivity.
• Share ideas on how results can be achieved more quickly.
• Examine the quality of products and customer service. Identify steps to improve in these areas.
• Build & reinforce a sense of urgency on key projects; help others understand the criticality of these efforts.
• Listens and responds effectively, seeks clear requirements, and follows up in a timely manner.
• Develop relationships with internal partners including Procurement, Material and Supplier Engineering, Quality Assurance, R&D, and suppliers/EMs.
• Review EM & Supplier Quality procedures and consider new ways to enhance effectiveness and share feedback with the process owners.
• Consider how to apply new ideas you generated in EM & Supplier Quality processes.
• Brainstorm and test new ideas with others and remain open to and acknowledge different points of view.
• Find ways to challenge the status quo and how things have always been done; bring new ideas or innovations to bear on existing efforts
• Develop your communication and influence skills to become a high impact presenter; seek feedback on your skills in this area.
• Identify & develop the skills necessary for future success.
• Get involved in non-profit activities aligned to the Credo.
External and Internal Interactions
• Main internal interactions are with Procurement, Material and Supplier Engineering, R&D Materials, Quality Assurance including Laboratory, Document Control
• Main external interactions are with Suppliers, EMs, and other client supplier quality groups.
• Minimum of 5 years of experience as a professional in a regulated industry, preferred Medical Device
• Demonstrates a basic understanding of the Medical Device Quality Systems, emphases on purchasing controls.
• Require working knowledge of Word, Power Point and Excel with competency in moderately complex functions for data analysis and trending.
• Experience in the Medical Device industry is preferred. Experience in the Pharmaceutical industry or Chemical, Packaging, or Plastics industry is an asset.
• FDA and ISO regulations knowledge. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL; Anvisa Australian TGA is preferred
Additional Position Requirements – Up to 30% travel, Full Time with week day business hours.