Supplier Quality Engineer responsible for supplier qualification, supplier corrective actions, PPAP, incoming inspection strategy, quality system compliance, and supplier process improvement for regulated medical device products. Job Requirements Experience with Supplier Corrective Action Requests (SCARs). Experience with Production Part Approval Process (PPAP). Experience using Agile and TrackWise. Knowledge of

ISO 13485

requirements. Knowledge of FDA Quality Management System Regulation (QMSR) requirements. Knowledge of geometric dimensioning and tolerancing. Experience with supplier development and supplier quality activities. Experience with supplier process improvement. Experience evaluating supplier performance and manufacturing capability. Experience supporting supplier changes throughout the product lifecycle. Experience defining receiving inspection requirements. Experience developing or supporting control plans. Experience with supplier qualification and approval processes. Preferred Skills Medical device supplier quality experience. Experience with Approved Supplier List management. Experience with Supplier Owned Quality programs. Experience developing product acceptance sampling strategies. Experience with test method validation. Experience supporting new product introduction and supplier qualification activities. Experience with purchased component and material qualification. Experience conducting supplier audits or supplier capability assessments. Job Responsibilities Qualify and monitor suppliers according to established quality requirements. Ensure purchased parts, materials, and services meet applicable quality and regulatory requirements. Initiate and manage SCAR activities. Support PPAP submissions and supplier qualification documentation. Monitor supplied components throughout the acquisition and manufacturing lifecycle. Investigate and resolve supplier-related quality issues. Evaluate supplier manufacturing processes, quality systems, and operational performance. Support supplier development and process improvement initiatives. Provide technical quality guidance for supplier changes. Ensure supplier changes comply with applicable regulatory, industry, and product requirements. Develop and maintain supplier control plans. Support development of product acceptance sampling strategies. Define receiving inspection requirements. Support test method validation for receiving and inspection methods. Maintain Approved Supplier List documentation and supplier quality records. Support supplier quality activities for new product development and sustaining products. Partner with engineering, sourcing, operations, and quality functions to prevent supplier-related defects. Track supplier performance and implement corrective actions when quality requirements are not met.

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.