Global Launch Quality Engineer

Responsibilities

• Evaluate customer quality expectations for new Medical, Industrial and A&D programs during pre-sale and opportunity assessment activities.
• Review customer contracts, statements of work, quality agreements, and quality clauses to identify quality risks and special requirements.
• Support cost modeling and feasibility assessments related to quality, inspection, and traceability.
• Participate in customer meetings and audits during business capture, providing quality input and expertise for regulated industries.
• Confirm customer or site supplier selection/qualification data, including build-to-print first articles and Bill-of-Material accuracy.
• Act as the quality lead for assigned NPIs and manufacturing transfers from customer or legacy manufacturing sites to Benchmark receiving manufacturing sites.
• Support process development, PFMEA, DFMEA (as applicable), control plans, and risk mitigation activities aligned with product quality, safety, and reliability expectations.
• Translate Medical, Industrial and A&D regulatory and customer requirements into executable quality launch plans, inspection strategies, and acceptance criteria.
• Ensure effective implementation of customer specifications, drawings, quality standards.
• Ensure inspection plan development for material transfers in compliance with Benchmark requirements prior to receipt.
• Ensure customer flow-downs for Production and Supply Chain are established including Quality Code assignments on Benchmark Item Numbers.
• Support factories start-up activities, including: First Article Inspection (FAI) and AS9102 packages (where applicable), Pilot builds, qualification builds, and Run-at-Rate, Process readiness and capability assessments.
• Support equipment and process validation, including IQ/OQ/PQ and process qualification as required for Medical, Industrial and A&D products.
• Participate in Manufacturing Readiness Review (MRR) with the site. (Work Instructions, Incoming\In-process\Final Inspection documentation, and relative training.)
• Ensure measurement systems, inspection methods, and test processes are defined, validated, and repeatable.
• Drive structured root cause analysis and corrective actions for launch-related issues using disciplined problem-solving methodologies.

Qualifications

• Bachelor’s degree in engineering or related technical discipline.
• 5+ years of experience in quality engineering within Medical, A&D, or other highly regulated electronics manufacturing environments.
• Hands-on experience with ISO 13485, FDA QMSR, and/or AS9100 environments.
• Proven experience leading or supporting NPIs and manufacturing transfers.
• Strong working knowledge of: DFMEA / PFMEA and risk-based quality planning, Control plans, inspection strategies, and traceability, Root cause analysis and corrective actions, Equipment, process validation, and qualification.
• Experience working directly with customers and regulatory expectations.
• Ability to travel domestically and internationally as required.