Job Overview

The Senior Quality & Reliability Engineer is responsible for maintaining and improving the quality, reliability, and compliance of existing products and manufacturing processes. This role manages customer complaints, investigates nonconformances, drives CAPAs, leads process-improvement initiatives, and ensures ongoing regulatory and quality system compliance. The engineer partners closely with Operations, Engineering, Supply Chain, and Customer Service to enhance product quality, reduce defects, and safeguard the customer experience. They are responsible for Sustaining Quality within the Assemblies value-stream, reporting to the Assemblies Quality Manager.

Job Requirements

• Lead investigations for customer complaints, perform root cause analysis, and coordinate cross-functional corrective actions.
• Drive the full lifecycle of Corrective and Preventive Actions (CAPAs), including problem definition, root cause identification, action planning, and effectiveness verification, ensuring CAPAs are documented per quality system requirements.
• Support Non-conforming material (NCR) investigations by performing technical assessments and providing guidance to technician staff to ensure accurate documentation, proper material handling, and timely completion of disposition activities.
• Lead quality reviews for Change Control Board (CCB) activities to assess engineering, supplier, and process changes while ensuring required risk analyses (FMEA), validation tasks, and documentation updates are completed.
• Support process validation studies for special processes to improve TE-Medical's quality assurance methodology. Support development of Product Validation Plans, IQ/OQ/PQ protocols, and Test Measurement Validations.
• Monitor and analyze key quality Key Performance Indicators (KPIs) and deliver dashboards and reports to leadership highlighting trends, risks, and recommended actions.
• Review and approve Engineering Change Orders (ECOs), deviations, and 8D corrective action reports to ensure technical accuracy, regulatory compliance, and alignment with quality and engineering standards.
• Drives continuous improvement initiatives to enhance the site quality system and product quality ensuring compliance to governing regulations and corporate policies and procedures.
• Identifies process and procedural gaps and ensures policies/procedures are implemented to fulfill the organizational business strategy.
• Complete required safety objectives by actively conducting Don’t Walk By observations, participating in regular Gemba walks, and consistently following and reinforcing all safety protocols to promote a safe, compliant, and continuously improving workplace environment.
• Understands and complies with all company rules and regulations.
• Other duties as required and assigned by Assemblies Quality Manager.

What your background should look like

• Bachelor’s Degree in Science, Engineering or related subject desirable.
• 5+ years relevant quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry. Extensive experience with Quality Risk Management, Reliability Engineering, Statistical Quality Control (SQC) and Root Cause Analysis (RCA).
• ASQ Certified Quality Engineer desirable
• Six Sigma Green/Black belt desirable
• Lead Auditor ISO 13485 certification a plus
• Quality experience in component and device manufacturing is preferred.
• Excellent organization and investigation skills are required.
• Excellent communication skills with a demonstrated ability to influence and lead.
• Strong team building skills with abilities in decision making and sound personal judgment
• Strong “hands-on” technical skills.
• Good working knowledge of ISO/FDA and other Product Development related regulatory requirements.
• Good coaching/mentoring skills.
• Experience with QMS, SAP, MS Word, Excel, Project Management & Analytics software.

Competencies