Supplier Quality Engineer
CPI International
- Georgetown, ON
- Permanent
- Full-time
- Act as the technical liaison between suppliers, supply chain, and internal engineering teams, ensuring accurate interpretation and flow-down of design, process, and quality requirements.
- Drive Design for Excellence (DFx) principles (DFM, DFA, DFT, DFR) to improve manufacturability, testability, reliability, and cost across the supply base.
- Lead and review DFMEA and PFMEA activities, ensuring risks are identified, mitigated, and continuously improved throughout the product lifecycle.
- Establish and standardize supplier quality business processes, including:
- Evaluate and approve suppliers based on technical capability, process maturity, and compliance with ISO 9001, ISO 13485, FDA QSR (21 CFR Part 820), and applicable regulatory standards.
- Lead Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP) activities for new product introductions and supplier changes.
- Own supplier nonconformance management, including SCAR issuance, root cause analysis (8D), and verification of effective Corrective and Preventive Actions (CAPA).
- Partner with engineering and suppliers to resolve complex technical issues, including RF performance deviations, thermal challenges, high-voltage breakdowns, and component reliability concerns.
- Review and approve technical documentation such as drawings, specifications, control plans, First Article Inspection Reports (FAIR), and device history records to ensure compliance and traceability.
- Develop and maintain supplier performance metrics (e.g., DPPM, yield, on-time delivery, field failure rates), using data analytics to drive continuous improvement.
- Conduct and lead supplier audits (on-site and remote), including process validation for critical components such as RF power modules, vacuum electron devices, and power electronics assemblies.
- Lead internal Quarterly Quality Reviews (QQRs), presenting supplier performance, risk assessments, and improvement plans to cross-functional leadership.
- Support capacity planning and supplier readiness for new and sustaining programs, contributing to make/buy decisions and risk mitigation strategies.
- Participate in design reviews, change control processes, and cross-functional problem-solving to ensure robust product quality and regulatory compliance
- Bachelor’s degree in electrical engineering, Mechanical Engineering, or a related technical discipline.
- 5+ years of experience in supplier quality engineering within high-reliability industries (RF systems, power electronics, or medical devices preferred).
- Strong technical expertise in:
- DFx methodologies (DFM, DFA, DFT, DFR)
- DFMEA/PFMEA development and risk analysis
- APQP and PPAP implementation
- Proven track record of establishing and scaling supplier quality processes, including capability analysis, scorecards, audit programs, and qualification systems.
- Deep understanding of quality management systems and regulatory standards, including ISO 9001, ISO 13485, MDSAP, CE Marking, and FDA QSR.
- Experience working with high-power RF amplifiers, high-voltage systems, or medical generator technologies.
- Strong background in failure analysis, root cause methodologies (8D, Fishbone, FTA), and reliability engineering.
- Hands-on experience with inspection methods, test equipment, and validation techniques for electronic and electromechanical systems.
- Demonstrated ability to lead cross-functional quality reviews and communicate technical risks, impacts, and mitigation strategies to stakeholders.
- Strong analytical, communication, and leadership skills with the ability to influence both internal teams and external suppliers.
- Experience in supply chain, NPI, and project management environments.
- Proficiency in Microsoft Office and data analysis tools.
- Must meet all CGP and ITAR compliance requirements