Sr. supplier quality engineer
Katalyst Healthcares and Life Sciences
• Job Summary:
The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems. Each supplier engineer is responsible for ensuring suppliers meet ISI requirements for product quality, cost, and service.
• Roles & Responsibilities:
The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems. Each supplier engineer is responsible for ensuring suppliers meet ISI requirements for product quality, cost, and service.
• Roles & Responsibilities:
- Support Value Engineering and Quality Improvement Part Qualification efforts.
- Lead Core Product Teams in defining appropriate Part Qualification requirements.
- Define testing and inspection requirements prior to system integration to maximize ISI factory efficiency.
- Support transfer of parts between suppliers.
- Complete Production Part Qualification Process deliverables including Supplier pFMEA, Special Process Validations, FAI, and Process Capability Analysis.
- Perform product/process risk analysis and ensure mitigations are implemented and effective prior to product introduction.
- Establish sustainable process capability at supplier and critical sub-tier suppliers.
- Support Manufacturing Line Escalations from manufacturing teams.
- Drive corrective actions using root cause tools (8D, 5 Why, etc.), determine true root cause, and implement effective corrective and preventive actions.
- Lead manufacturing process selection considering process quality, long-term capacity, and total lifecycle cost.
- Identify where DFM is appropriate to achieve higher quality, lower costs, or better supply chain capacity.
- Educate internal customers and suppliers regarding supplier quality, process and operational capabilities, best value manufacturing methods, and tooling for key supplier processes.
- Drive improvements to ISI requirements by proposing and managing changes to specifications and drawings through the ECO process.
- Manage planning and implementation of supplier change management projects using the Supplier Change Request (SCR) process post Design V&V.
- Provide status of supply chain readiness (quality, capacity, delivery) for major production process changes.
- Work cross-functionally to improve supplier engineering processes.
- Support supplier selection by working with Product Design, Commodity Managers, and stakeholders to identify high capability suppliers.
- Evaluate new suppliers through informal and formal assessments, supporting lead auditors in QMS evaluations.
- Support audit teams in addressing findings to develop suppliers' quality and business systems.
- Manage supplier relationships to effectively partner with ISI suppliers.
- BS degree in Engineering field.
- 10 years of related experience in Manufacturing, Supplier Process Engineering, Design, or related field.
- Excellent written and verbal communication skills.
- Experience creating and aggregating DFM feedback.
- Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities.
- Experience with a wide range of manufacturing processes including machining (4 & 5-axis, FMS, bar-fed lathes), metal fabrication, welding, bonding processes, plastic injection molding, die casting, thixomolding, mechanical motion products, motion control products, and sensors.
- Knowledge of pFMEA, process validation, inspection and test techniques.
- Familiarity with 21 CFR Part 820 and ISO 13485; experience auditing suppliers to these standards preferred.
- Understanding of GDP and QMS methods.
- Experience in a medical device company preferred.
- Experience with low-volume, high-mix production environments preferred.
- Significant computer experience using Windows, Word, Excel, Access, and ERP systems (preferably SAP).
- Ability to read and interpret detailed specifications and schematics and communicate technical information.
- Proven ability to motivate suppliers and lead teams to solve technical and process problems.
- Ability to travel to suppliers domestically and internationally as needed.
Vacancy posted 3 days ago
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