The Supplier Quality Engineer drives supplier quality, process validation, APQP execution, and corrective action activities across complex manufactured components and assemblies. Job Requirements Bachelor's degree in Engineering, preferably Mechanical Engineering or Biomedical Engineering. 10+ years of related engineering experience in manufacturing engineering, product quality, validation, or verification. 5+ years of experience leading non-conformance resolution and manufacturing process validation and verification. Subject matter expertise in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Experience with APQP, PFMEA, process validation, process verification, and test method validation. Experience with plastic, metal, and electronic commodities. Experience evaluating Critical-to-Satisfaction (CTS) and Critical-to-Quality (CTQ) requirements. Ability to travel approximately 20%. Preferred Skills Master's degree in Engineering.

ISO 13485

Lead Auditor certification. Experience with supplier audits, supplier qualification, quality agreements, and change notice agreements. Experience with Supplier Corrective Action Requests (SCARs). Experience with value stream mapping and continuous improvement initiatives. Job Responsibilities Perform process validation and verification activities for console, catheter, and related manufactured components. Partner with R D and Quality Design Assurance on Design for Manufacturability and part risk management activities. Support DFMEA and PFMEA activities throughout product and process development. Perform process validation, process verification, test method validation, and CTS/CTQ assessments in accordance with APQP requirements. Support supplier qualification activities, including audits, quality agreements, and change notice agreements. Investigate and resolve First Article Inspection (FAI) and APQP failures. Perform value stream mapping and process analysis. Investigate supplier-related defects and implement corrective actions through the SCAR process. Monitor supplier quality performance for components, subassemblies, and assemblies. Manage supplier improvement activities and supplier quality performance monitoring. Provide quality oversight for supplier-initiated product and process changes. Evaluate supplier change requests for regulatory impact and required validation activities. Lead process validation activities associated with supplier product or process changes. Develop and oversee supplier process validation plans, including equipment qualification activities. Lead continuous improvement projects based on process trends, product trends, quality issues, industry standards, and regulatory requirements.

Pay:

37-49/hr Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details:

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for

Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.