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 Overview The Quality Manager has complete site responsibility for Quality: 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. * Manages and provides resources for quality engineering, inspection, measurement, and test, compliant handling, non-conforming products and MRB resolution * Ensure compliance to FDA QSR, ISO, MDD and other applicable requirements. * Ensure product safety, reliability and quality through the effective us of quality planning, risk analysis, statical 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. * Teaches, trains, and develops quality personnel to assure continuity and personal growth. * Understands and complies with all company rules and regulations. * Reports unsafe conditions and practices to management. * Immediately reports injuries to management. What your background should look like: Skills, Experience and Education * 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. * 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 * 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 #TANAAB #LI-ONSITE Competencies Motivating Others Managing and Measuring Work Building Effective Teams Values: Integrity, Accountability, Inclusion, Innovation, Teamwork SET : Strategy, Execution, Talent (for managers) COMPENSATION * Competitive base salary commensurate with experience: $133,000 - $199,800 (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/Vets Location: WILSONVILLE, OR, US, 97070 City: WILSONVILLE State: OR Country/Region: US Travel: Less than 10% Requisition ID: 131066 Alternative Locations: Function: Engineering & Technology