Description

Own supplier quality, process validation, and continuous improvement initiatives across the supply chain.

This role is on-site.

Responsibilities

• Execute Part Qualification (PPQP) deliverables, including supplier pFMEA, process validations (IQ/OQ/PQ), inspection reports, Gage R&R, and process capability analysis.
• Manage supplier changes, including manufacturing process modifications, production optimization, facility changes, and new equipment or line validations.
• Drive closure of supplier variances through root cause analysis and corrective action (CAPA) documentation.
• Lead new product introduction efforts by evaluating launch readiness, developing ramp plans, and applying DFM principles to improve manufacturability.
• Implement Six Sigma, Lean, and SPC methodologies to drive supplier process performance, cost reductions, and risk mitigation.

Required Skills

• BS in Engineering with 8+ years of related experience, or MS in Engineering with 6+ years.
• Proficiency in pFMEA, process validation, root cause investigation, and statistical analysis.
• Strong knowledge of manufacturing processes such as Machining, Plastic Injection Molding, Metal Injection Molding, or Contract Manufacturing.
• Experience with document management systems and ERP systems, preferably Agile and SAP.
• Proven ability to lead technical problem-solving and manage multiple concurrent projects without managerial guidance.
• Excellent written and verbal communication skills, including executive-level presentations.
• Strong project management and interpersonal skills for effective supplier collaboration.

Preferred Skills

• Knowledge of 21 CFR Part 820 and ISO 13485 regulations.
• Experience in a high-volume medical device company.
• Ability to travel to supplier sites as needed.

Key Skills

Education

Bachelor's degree