At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job OverviewThe Quality Manager has complete site responsibility for Quality at our Wilsonville, OR location: ensuring that processes are suitably designed and implemented to maintain a continually effective and complaint quality system; representing the organization to external parties regarding the QMS (e.g., customer, assessor, FDA & other regulatory entities); leading quality improvement initiatives in support of customer and TE Connectivity Medical Business Unit objectives; allocating resources quickly and effectively to support business needs; providing exceptional service to the business unit to assure the shipment of quality products on time; making timely decisions to mitigate risk and assure rapid issue resolution.
Responsibilities: - Manages plant quality staff across quality systems and product quality.
- Oversees the quality and documentation system and quality records program.
- Manages QMS processes for management review, CAPA, regulatory agencies, customer and internal audits.
- Manages and provides resources for new product development, quality engineering, inspection, measurement, and test, complaint handling, non-conforming product and MRB resolution.
- Ensures compliance to FDA QSR, ISO, MDD and other applicable requirements.
- Site Management Representative for the TEM quality system.
- Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis, statistical methods and process controls.
- Provides sales and marketing support in explaining quality system and regulatory compliance capability to customers.
- Contributes with the strategic Site team effort to accomplish results as needed
- Provides leadership in the continuing evolution, improvement, and efficiency of the quality function.
- Develops quality personnel to assure continuity and personal growth.
- Understands and complies with all company rules and regulations.
- Builds a Safe and Inclusive environment
What your background should look like: - 10 years or more in a quality function with 5 years or more in management position.
- BS/BA degree with a scientific/engineering emphasis required.
- Leadership skills
- Technical discipline or quality professional training.
- Statistical techniques, metrology, and process analysis training.
- Quality system design and implementation experience.
- Lead and supportive on external audits.
- Risk management .
- Regulatory requirements and reporting responsibilities.
- Supply chain development and management.
- Strong analytical skills and attention to detail.
- Excellent interpersonal and written communication skills.
- Demonstrated ability to effectively organize, prioritize and accomplish multiple tasks, make decision and solve problems independently.
- A thorough knowledge of 21 CFR and ISO 13485.
- Commitment to ethical conduct and responsibility.
- Experience with MS Word, Excel, Project Management and Analytics software
CompetenciesMotivating OthersManaging and Measuring WorkBuilding Effective TeamsValues: Integrity, Accountability, Inclusion, Innovation, TeamworkSET : Strategy, Execution, Talent (for managers)
ABOUT TE CONNECTIVITYTE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, renewable energy, automated factories, data centers, medical technology and more. With more than 85,000 employees, including 8,000 engineers, working alongside customers in approximately 140 countries. TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat, Instagram and X (formerly Twitter).
COMPENSATION• Competitive base salary commensurate with experience: $121,920 - $182,880 (subject to change dependent on physical location)• Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.• Total Compensation = Base Salary + Incentive(s) + Benefits
BENEFITS• 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/VetsLocation: