Description

You will own the implementation and management of quality engineering, purchasing controls, and supplier quality processes for manufacturing materials and components.

Responsibilities

• Evaluate supplier critical quality processes and ensure adherence to regulatory requirements.
• Drive supplier improvements using SQIPs and lead the Supplier Change Notice process.
• Qualify and sustain supplier sub-processes, performing validations for critical processes impacting part quality.
• Execute SCAR management and manage the status of suppliers on the Approved Supplier List.
• Perform third-party product compatibility risk assessments with R&D and Procurement.

Required Skills

• Minimum 4 to 8 years of experience establishing and maintaining regulated supplier management systems.
• Extensive experience within the medical device domain industry.
• Proven experience with APQP (IQ, OQ, PQ) and PPAP.
• Experience in process improvement methodologies and organizational change management.
• Familiarity with manufacturing processes such as welding, soldering, crimping, injection molding, and casting.
• Demonstrated ability to write technical protocols and reports.
• Bachelor's degree in engineering or a science discipline, or equivalent experience.
• Strong capability in stakeholder influencing and conflict resolution.
• Experience with technical drawings and component specifications.

Key Skills

Education

Bachelor's degree