Leads quality engineering activities within medical device manufacturing, including process validation, engineering changes, complaint management, and corrective and preventive actions to ensure product quality and regulatory compliance. Job Requirements Bachelor's degree in Engineering or a related technical field. Minimum of 12 years of relevant quality engineering experience. Experience in the medical device manufacturing industry. Strong background in process engineering and manufacturing quality systems. Experience developing, writing, and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation protocols. Experience managing manufacturing process changes and evaluating their impact on product quality and validated processes. Experience with medical device complaint management and investigation processes. Experience developing, implementing, and managing Corrective and Preventive Actions (CAPA). Knowledge of medical device quality management systems and regulatory requirements. Experience performing root cause analysis and implementing corrective actions for manufacturing and product quality issues. Ability to evaluate manufacturing processes, validation results, and quality documentation for compliance with established requirements. Must be eligible for employment without H-1B sponsorship. Direct employment required; contract-to-contract (C2C) arrangements not accepted. Preferred Skills Experience with FDA medical device quality regulations and

ISO 13485

standards. Experience leading process validation activities in regulated medical device manufacturing environments. Knowledge of process risk assessment, Failure Mode and Effects Analysis (FMEA), and change control procedures. Experience conducting investigations related to product complaints, nonconformances, and manufacturing defects. Experience with statistical process control, process capability analysis, and validation data evaluation. Experience supporting regulatory audits and quality management system inspections. Experience implementing manufacturing process improvements while maintaining validated process requirements. Previous successful experience in a similar medical device quality engineering role. Local candidates preferred. Job Responsibilities Lead quality engineering activities supporting medical device manufacturing and process engineering operations. Develop, author, review, and execute IQ, OQ, and PQ validation protocols. Prepare validation reports and maintain documentation demonstrating process compliance and performance. Evaluate manufacturing process changes and determine validation, testing, and regulatory documentation requirements. Support implementation and verification of process improvements and engineering changes. Manage medical device complaint investigations, including root cause analysis, documentation, and corrective action development. Develop, implement, and monitor CAPA activities to address product and process quality issues. Investigate manufacturing nonconformances, process deviations, and product quality concerns. Analyze quality data and manufacturing performance to identify recurring defects and improvement opportunities. Conduct risk assessments related to manufacturing processes, equipment changes, and product quality. Ensure validation protocols, process changes, and quality documentation comply with applicable medical device regulations and quality standards. Review and approve quality engineering documentation, validation results, and corrective action records. Support internal and external quality audits, regulatory inspections, and compliance assessments. Coordinate quality engineering activities with manufacturing, process engineering, validation, and regulatory functions. Implement corrective and preventive measures to improve process reliability, product quality, and regulatory compliance. Provide technical oversight for manufacturing process validation, change control, and complaint management activities.

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.