Site Quality Leader

Job Overview

The Site Quality Manager is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions. This position ensures full compliance with regulatory requirements such as 21 CFR 820, ISO
13485, MDR, and other applicable regulations including production and process controls. The Site Quality Manager reports to the Global Head of Quality Operations.

• Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.
• Develop and implement systems to support development and production teams in areas such as quality planning, inspection techniques, sampling methods, statistical analysis, and application of required regulatory standards.
• Develop and implement procedures and systems to ensure that products manufactured for human use meet design and functional specifications; these systems include delivery of raw materials and components, manufactured devices and equipment, and associated documentation.
• Develop, track, and report on administrative systems such as department metrics, objectives, personnel development, and training.
• Support regulatory agency and customer quality audits.
• Ensure the conformity of components and products are appropriately checked in accordance with the Quality Management System before release.
• Assist and train associates in concepts of probability and statistics.
• Lead failure appraisal and analysis (internal and external).
• Place products or processes on hold when necessary.
• Design and develop forms and instructions for recording, evaluating, and reporting quality data.
• Manage the 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 and/or process related issues.
• Lead cross‑functional teams to support the resolution of product and/or process related issues or objectives.
• Work with suppliers of raw materials and components to improve product quality and resolve quality issues.
• Be innovative, knowledgeable, and intensely committed to ensuring that every product and service conforms 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 and technical skills.
• Interpersonal, oral, and written communication skills.
• Teamwork, judgment, motivation, planning/organizing, professionalism, adaptability, dependability, initiative.
• Excellent computer skills and high motivation with a sense of urgency.
• Proficiency in advanced statistical methodologies.

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

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

This position may require up to 10% travel to TE sites and customer locations as required.

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

EOE, Including Disability/Vets