Supplier Quality / Component Engineer - Medical Devices
Job Description
Job Description
Job Description
Primary Function:
Responsible for ensuring suppliers meet ISI requirements for cost, quality, delivery, and service. Drive suppliers to continuously improve business and manufacturing processes, evaluate and select suppliers, guide engineering in supplier selection for new products, provide DFM input to designs, and monitor supplier performance.
Essential Duties & Responsibilities
§ Select and evaluate suppliers, including identifying new suppliers for existing or new commodities.
§ Conduct on-site supplier assessments and QMS audits; address non-conformities.
§ Collaborate with suppliers and ISI engineering on new product introductions.
§ Complete part production qualification process (PPQP), including spFMEA, special process validations, process capability, MSA, capacity analysis, and FAIR.
§ Develop supplier readiness plans based on forecasts, capacity, quality performance, and process capability.
§ Perform DFM by engaging suppliers early in the development cycle for manufacturability improvements.
§ Lead and resolve supply continuity/quality issues through root cause analysis and corrective actions using SCARs and SCRs.
§ Monitor supplier performance and initiate improvement activities.
§ Drive continuous improvement at suppliers using best practices in project management, Six Sigma, Lean, and SPC.
§ Develop and track metrics for cost, delivery, quality, capacity, and capability.
§ Drive changes to ISI specifications and drawings, including ECO implementation.
§ Prepare and deliver supplier communications (e.g., QBRs, Supplier Summits).
§ Identify opportunities for cost reduction and quality improvement; provide data-driven strategies and plans.
Required Skills & Experience
§ Strong knowledge of 21 CFR Part 820 and ISO 13485; auditing experience preferred.
§ Practical knowledge of PFMEAs and process validations.
§ Proven problem-solving and project management skills.
§ Strong written and verbal communication, including executive-level presentations.
§ Experience implementing Lean, Six Sigma, and SPC programs at suppliers.
§ Knowledge of the part production qualification process.
§ Proficiency with Windows, Word, Excel, Access, and ERP systems (SAP preferred).
§ Experience with CAD/3D modeling tools a plus.
§ Experience in high-volume medical device manufacturing is a plus.
Education & Training
§ BS degree in Engineering (Master’s preferred).
§ Experience with statistical analysis software (Minitab).
§ Ability to read and interpret detailed mechanical drawings (GD&T).
Working Conditions
Ability to travel to suppliers as needed (domestic and international).
Preferred Skills & Experience
Medical device industry experience.
Supplier management background.
Experience with manufacturing processes (injection molding, machining, etc.).
Agile or clinical control system knowledge.
3D CAD experience.
3–5 years of relevant experience required.
Minimum Bachelor’s degree required.
Company DescriptionDella Infotech Inc is in the staffing business for 10 years. Over the years, we have placed hundreds of candidates to various temp and permanent positions with our 50+ happy clients all over US and Canada including Fortune 500 corporations.
Company Description
Della Infotech Inc is in the staffing business for 10 years. Over the years, we have placed hundreds of candidates to various temp and permanent positions with our 50+ happy clients all over US and Canada including Fortune 500 corporations.