Supplier Quality Engineer responsible for supplier qualification, change control, validation, risk management, and quality system compliance within a regulated medical device environment. Job Requirements Bachelor's degree in Engineering. 4+ years of medical device industry experience. Experience with Supplier Change Requests (SCR). Experience with validation activities. Experience with Test Method Validation (TMV). Experience with Production Part Approval Process (PPAP). Experience with Supplier Corrective and Preventive Action (SCAPA). Experience working within a Quality Management System (QMS). Experience with QMS development and implementation. Experience with supplier selection and qualification. Experience performing supplier risk assessments. Knowledge of

ISO 13485

requirements. Knowledge of applicable 21 CFR quality system requirements. Preferred Skills Supplier quality engineering experience in a regulated manufacturing environment. Experience conducting supplier audits. Experience supporting supplier performance monitoring. Experience with supplier corrective action investigations. Experience with validation documentation and change control. Experience with medical device risk management processes. Experience supporting regulatory or quality system audits. Job Responsibilities Evaluate and qualify new and existing suppliers. Support supplier selection and approval activities. Review and process Supplier Change Requests. Assess supplier changes for quality, validation, and regulatory impact. Support validation and Test Method Validation activities. Support PPAP documentation and approval activities. Initiate, manage, and close supplier corrective and preventive actions. Perform supplier risk assessments and maintain risk documentation. Develop and maintain QMS procedures and documentation. Monitor supplier quality performance and identify recurring quality issues. Support supplier audits and quality system assessments. Investigate supplier-related nonconformances. Ensure supplier quality activities comply with ISO 13485 and applicable 21 CFR requirements. Maintain supplier quality records, qualification documentation, and change-control records.

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.