Site Quality Leader

Job Overview

The Site Quality Manager is responsible for administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions, ensuring compliance with 21 CFR 820, ISO
13485, MDR and other applicable regulations. The Site Quality Manager reports to the Global Head of Quality Operations.

• Ensure material review boards are in place, including timely disposition of products and initiation of corrective/preventive actions.
• Develop and implement systems to support development and production teams in quality planning (inspection techniques, sampling methods), statistical analysis, and application of regulatory standards.
• Develop procedures and systems to ensure manufactured products meet design and functional specifications, covering raw materials, components, manufactured devices, and associated documentation.
• Track and report on department metrics, objectives, personnel development, and training.
• Support regulatory agency and customer quality audits.
• Ensure component and product conformity in accordance with the Quality Management System before release.
• Train associates in probability and statistics.
• Conduct failure analysis (internal and external).
• Place products or processes on hold as needed.
• Design and develop forms and instructions for recording, evaluating, and reporting quality data.
• Manage corrective and preventive action program.
• Assist in test equipment selection and validation based on operational/quality requirements.
• Utilize formal problem‑solving techniques to resolve product or process issues.
• Lead cross‑functional teams to support resolution of product or process issues or objectives.
• Collaborate with suppliers of raw materials and components to improve product quality and resolve quality issues.
• Be innovative, knowledgeable, and committed to ensuring all products and services conform to FDA and quality system regulations.

• Degree with a scientific or engineering emphasis.
• ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.
• Minimum of ten (10) years experience in a related regulated environment.
• Experience should include senior level positions within medical device organizations.

Analytical, design, and problem‑solving skills; project management; technical skills; interpersonal skills; oral and written communication; teamwork; judgment; motivation; planning/organizing; professionalism; adaptability; dependability; initiative; excellent computer skills; highly motivated with a sense of urgency; proficiency in advanced statistical methodologies.

This position supervises Senior Quality Engineers and Quality Engineers reporting directly or indirectly.

All quality functions of Quality Operations, Validation & Calibration Engineering, and Microbiology.

Up to 10% travel to TE sites and customer locations, as required.

• Competitive base salary commensurate with experience: $136,000 – $170,000 (subject to change depending on location).
• Total compensation includes base salary, incentive(s), and benefits.

• Comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off, and voluntary benefits.

TE Connectivity is an equal opportunity employer. We welcome applicants with disabilities and veterans.