Required Education:

• Bachelor's DegreeRequired Skills:

• Quality Engineering experience in medical devices, regulated manufacturing, life sciences, or another highly controlled manufacturing environment.
• 2+ years of hands-on ownership of CAPA, non-conformances, MRB, and corrective actions, ideally using an electronic QMS such as TrackWise.
• Demonstrated experience managing supplier quality issues, SCARs, supplier corrective actions, and supplier-driven non-conformances from investigation through closure.
• Strong experience with PPAP, supplier change controls, process validation/qualification, MSA, and manufacturing process improvements.
• Proven ability to lead cross-functional root-cause investigations and complaint/field-action activities, translating quality data into effective corrective and preventive actions.

Overview:

Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.

Key Areas of Responsibility:

• Work closely with Operations and the business functions to ensure quality performance of product and processes.

Non-Conformances

• Collaborate with Internal cross-functional and Supplier teams to address top quality issues.
• Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise.
• Support execution and analysis of manufacturing related complaint investigations and product field actions.
• Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.

Supplier Activities

• Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.
• Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval o Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
• Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.

Process Improvements/Validation

• Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.
• Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.
• Participate in and potentially lead the creation and/or review of new or modified procedures.
• Support the development and review of process and equipment validation/qualification and MSA of internal processes.
• Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
• Perform other related duties as assigned.
• Only those lawfully authorized to work in the designated country associated with the position will be considered.
• Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.

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