Description
Supplier Quality Engineer
Position Summary
- The Supplier Quality Engineer role will provide quality assurance input into the management of business critical suppliers.
- This position will support elimination of supply chain risks via EM/vendor partnerships & assessments and ensure suppliers comply with company requirements as defined in material specifications, CTQ's, process control plans, quality agreements and other defined requirements. Key areas of focus within supplier quality are risk management/communication, root cause investigation and defect resolution, process capability/process improvement, performance monitoring/reporting, and general quality assurance support.
- Additionally, this position will be responsible for completing department and franchise objectives as assigned. Specific responsibilities are detailed below.
Main duties and responsibilities
- Support supplier quality department activities associated with Supplier Risk Identification & Management.
- This includes working with suppliers to identify areas of high risk within their processes; execution of supplier risk & control plan assessments and select quality audits; trending and monitoring sources of supplier quality data such as plant non-conformances, supplier scorecards and performance metrics to establish proactive risk mitigation plans; collaborating with internal and supplier partners to improve process capabilities while eliminating sources of supplier variation.
- Support supplier quality department activities associated with resolving supplier quality issues, such as non-conforming raw materials and/or internal run-ability challenges.
- This includes working with supplier and resources to perform root cause analysis/failure investigations, identifying and approving of supplier corrective actions, while monitoring the supplier's implementation of effectiveness.
- Support supplier quality department activities associated with Supplier Quality Assurance and Process Improvement.
- This includes gathering supplier quality data for supplier performance meetings such as Management Review and Supplier Quality Business Reviews; evaluation of new suppliers and supplier change notifications; providing quality and compliance guidance for suppliers including 3rd party inspection support; and driving implementation of Supplier Management best practices.
Education and Experience
- A minimum of a Diploma/Primary degree is required, preferably in an Engineering, Life Science, or related discipline.
- Strong communication, teamwork, and analytical problem solving skills are a must.
- A minimum of 5 years of experience in a highly regulated industry is required.
- Experience in the Medical Device industry is preferred.
- Experience in the Pharmaceutical or Chemical industry is an asset. FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge preferred.
- Strength in root cause analysis/failure investigations, packaging, machining, chemical manufacturing processes and injection molding are highly desired.
- Statistical Process Controls, Six Sigma, Lean or ASQ CQE Certification and trainings is an asset.
- Supplier auditing background is an asset.