QUALITY ENGINEERING MANAGER
Tyco Electronics / Medical Products is the world's leading producer of Electronic Interconnect Systems for medical OEM customers. Ours is a dynamic work environment where you can capture every bit of potential and possibility out of your career. We are known by our customers for exceptional quality, innovation and responsiveness. Our products demand density, flexibility and signal integrity previously thought impossible. If you enjoy working in a fast-moving environment that values customer interface at all levels and focuses on developing innovative solutions to customers' design needs, come join our company.
We are seeking a Quality Engineering Manager for our Wilsonville facility, just 10 miles from Portland, Oregon. Tyco Electronics / Medical Products offers a competitive compensation and benefits package. For more information about our positions, products and/or to apply for this position, please visit our web site at www.precisionint.com. We are an EEO Employer Dedicated To Work Force Diversity.
RESPONSIBILITIES
- Educate, train, and effectively transfer knowledge of medical manufacturing and applicable regulatory requirements to engineering, manufacturing auditing, and organizational resources.
- Responsible for hiring, performance management, employee development, leadership and motivation for quality engineering functions.
- Responsible for Inspection and acceptance processes for purchased and manufactured products and materials.
- Serve as chairperson of the Material Review Board (MRB).
- Support Supplier qualification and monitoring through audits, evaluations and Scorecards.
- Plan projects and meet project schedules.
- Gather and analyze data to improve product and process performance.
- Understand and comply with all regulatory requirements.
- Manage the Complaint handling processes to meet customer expectations and regulatory requirements.
- Train quality engineers and quality personnel in quality tools and techniques.
MINIMUM QUALIFICATIONS
- Five or more years experience in quality engineering, medical manufacturing and medical quality system environment.
- Knowledge and experience in designing quality management systems to meet ISO 13485: 2003 and FDA requirements.
- BS in engineering or related field.
- Knowledge and experience in designing quality management systems to meet ISO 13485: 2003 and FDA requirements.
- Training and significant experience in implementing six sigma and lean.
- Strong metrology background.