Principal Engineer, Supplier Quality Assurance
2 days ago
This role is responsible for administering regulatory compliance activities related to New World Medical's (NWM) Supplier Management. The successful candidate will establish systems for managing suppliers, including approval, monitoring, and validation processes. This position requires strategic thinking and influencing others within the organization to shape the technical direction of complex quality projects.
Key Responsibilities- Lead projects with limited scope for Supplier Quality on NPD projects, articulating project goals, technical challenges, and progress to key stakeholders.
- Lead the PPAP process with suppliers to establish robust validated processes, including measurement methodologies (Gage R&R).
- Work with suppliers and New World Medical's R&D, Sustaining, and Production Department to establish, maintain, and assess associated risks of their controlled manufacturing processes.
- Build and maintain relationships with suppliers to establish and verify/audit control methods suitable to the nature of the parts they supply.
- Schedule, manage, and conduct audits of New World Medical existing and potential new suppliers to assess compliance to all applicable Standards, Regulations, and New World Medical Requirements.
- Identify compliance risks to current standards/regulations and assist in the planning and execution of Quality System improvements to mitigate those risks.
- Drive continuous improvement efforts through facilitating, leading, and collaborating with cross-functional teams, including NWM and suppliers.
- 7+ years of experience with a Bachelor's degree or 10+ years of experience.
- Direct experience with supplier producing product and parts in a regulatory environment (i.e. GMPs, ISO13485, 21 CFR Part 820, etc.) preferred.
- Must have knowledge of Quality Engineering discipline, including statistics.
- Strong working knowledge of DMAIC/Six Sigma problem-solving process. Belt certified is a plus.
- Competent in Process Audit, CAPA, PPAP, Equipment Validation, and Gage R&R.
- Certified Auditor Qualification or equivalent is required.
- Must be able to remain in a stationary position at least 50% of the time.
- Occasionally move about inside the office and travel to and from office buildings to access file cabinets, employee offices, office machinery, etc.
- Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
- Ability to listen and speak with employees and suppliers. Must be able to exchange accurate information in these situations.
- View and type on computer screens for long periods of time.
$130,000-$146,000/per year
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