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Title: Supplier Development Quality Engineer
The Supplier Development Quality Engineer (SDQE) will develop, implement, support, and improve the processes for qualifying new suppliers, analyze and improve supplier performance, lead investigations of any rejected supplied components or customer complaints linked to supplied components, implement corrective actions or quality plans internally as well as at the suppliers to prevent repeat non-conformances using Quality Tools (FMEA, CpK, SPC, etc.), establish a supplier audit schedule based on sound risk-based methodology, and conduct supplier audits according to the schedule or based on need.
• Establish and maintain supplier quality process and procedures to meet company policies and regulatory requirements.
• Manage the supplier quality program including, but not limited to, Supplier change notifications, supplier corrective actions and supplier qualifications.
• Support supplier selection and approval by performing quality & compliance assessments/audits of proposed new suppliers and ongoing monitoring of existing suppliers.
• Develop, implement, monitor and maintain meaningful metrics to demonstrate the effectiveness of the supplier quality processes. Monitor supplier performance (KPI's) through regular communication, frequent reporting and follow-up. Track, trend and communicate supplier quality metrics providing input to periodic Supplier Performance Monitoring meetings and Management Reviews.
• Report metrics and provide input to management reviews where supplier issues are discussed, advising management of potential risks and providing recommendations.
• Participate with performance of risk classification, selection, evaluation and qualification of suppliers per purchasing control requirements and support their placement on the approved supplier list (ASL).
• Work closely with the Purchasing Team to qualify suppliers and perform both initial and periodic follow-up assessments/audits. Act as Lead Auditor during supplier audits. Ensure management of supplier audits from planning to completion.
• Issue Supplier corrective action requests (SCAR) for supplier corrective/preventive action activities.
• Approve and monitor supplier CAPA/SCAR plans and activities to closure, including objective evidence of effectiveness.
• Drive suppliers to perform effective root cause analysis and implement corrective action for supplier process and product related non-conformances.
• Review and approve supplier records including but not exclusive to: contracts, quality agreements, quality plans, change requests, CAPAs, NCRs, verification and validation protocols and reports.
• Collaborate with other department stakeholders to effectively review supplier performance.
• Participate in design changes related to supplier provided materials.Coordinate the preparation of quality test/inspection plans (including design verification & validation) for proposed new components and/or existing components from a new supplier.
• Participate and/or lead cross functional meetings and process improvement teams related to supplier improvement and utilize established quality improvement and lean tools.
• Support OEM projects for supplier and product qualification to meet medical device standards and relevant regulations.
• Establish and implement a divisional standard internal audit process that allows for consistency amongst the APD division sites.
• Travel is required – approximately 20-50%, depending on status of suppliers, supplier issues, and audit schedule.
• Bachelors or Master's Degree in Life Sciences or an engineering discipline or an equivalent combination of education, experience and/or licensure/certification.
• The required skills, knowledge and abilities that are typically acquired through a minimum of 5 years in supplier quality assurance.
• Knowledge of overall regulatory requirements associated with medical products into worldwide markets.
• Experience and knowledge of ISO13485/ FDA 21 Part 820 requirements with particular focus of supplier controls and supplier performance management, and the ability to apply the knowledge to the business to ensure compliance to the regulations.
• Must have experience performing effective root cause analysis, corrective and preventive actions.
• Strong and effective communication skills (both written and oral).
• Ability to interact with supplier and internal personnel in a professional manner to build productive relationships.
• Ability to focus on continual improvement practices using causal analysis tools to drive corrective and preventive actions.
• Detail oriented and the ability to lead multiple projects and activities assigned with minimal supervision.
• Must have demonstrated hands on, results oriented, multi-tasking response to the urgent needs of the company and show a strong track record of meeting deadlines.
• Ability to work in a timeline driven environment.
• Lead auditor training required, Lead Auditor certification (CQA/ASQ/ISO) is preferred.
• Lean Six Sigma Green or Black Belt certification preferred.
• Experience working with Medical Device/IVD regulated products preferred.
• Up to 50% travel
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