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 Site Quality Manager is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions. This position is responsible for ensuring full compliance to the regulatory requirements of 21 CFR 820, ISO13485, MDR and other applicable regulations including production and process controls. The Site Quality Manager will report to the Global Head of Quality Operations.
Duties & Responsibilities:
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 assure that development as well as production teams receive support in the following areas:
- Quality planning, including inspection techniques and sampling methods
- Statistical Analysis
- Application of required regulatory standards
- Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum:
- Delivery of raw materials and components
- Manufactured devices and equipment
- Documentation associated with these functions
- Develop, track, and report on the following administrative systems:
- Department metrics
- Department objectives
- Personnel development and training
Support regulatory agency and customer quality audits. Ensure the conformity of the components and products are appropriately checked in accordance with the Quality Management System before release. Responsible for assisting and training associates in concepts of probability and statistics. Responsible for failure appraisal and analysis (internal and external).Authority to place products or processes on hold. Design and develop forms and instructions for recording, evaluating, and reporting quality data. Corrective and Preventive Action program
Based on operational/quality requirements, assist in test equipment selection and validation. Utilize formal problem solving techniques to resolve product and/or process related issues. As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives. Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues. Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..What your background should look like
Education/Experience:
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 positions at senior levels within the medical device organizations.
Key Requirements:
To perform this job successfully, an individual should demonstrate the following competencies: Analytical, Design, Problem Solving Project Management, Technical Skills, Interpersonal Skills, Oral and Written Communication Skills, Teamwork, Judgment Motivation and Planning/Organizing Professionalism, Adaptability, Dependability, Initiative, Excellent computer skills Highly Motivated with a sense of urgency and be Proficient in the use and application of advanced statistical methodologies.
SUPERVISORY RESPONSIBILITIES:
This position has Senior Quality Engineers, and Quality Engineers reporting directly or indirectly to it. Direct Responsibility: All quality functions of Quality Operations, Validation & Calibration Engineering and Microbiology,
TRAVEL:
This position may require up to 10% travel TE sites and customer locations as required, dependent on the needs of the organization #TANAJC #LI-onsite CompetenciesSET : Strategy, Execution, Talent (for managers)ABOUT TE CONNECTIVITYTE Connectivity plc (NYSE: TEL) is a global industrial technology leader creating a safer, sustainable, productive, and connected future. As a trusted innovation partner, our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, energy networks, automated factories, data centers enabling artificial intelligence, and more. Our more than 90,000 employees, including 10,000 engineers, work alongside customers in approximately 130 countries. In a world that is racing ahead, TE ensures that EVERY CONNECTION COUNTS. Learn more at and on LinkedIn, Facebook, WeChat, Instagram and X (formerly Twitter).COMPENSATIONCompetitive base salary commensurate with experience: $136,000 – 170,000 (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) + BenefitsBENEFITSA comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits. EOE, Including Disability/VetsIMPORTANT NOTICE REGARDING RECRUITMENT FRAUDTE Connectivity has become aware of fraudulent recruitment activities being conducted by individuals or organizations falsely claiming to represent TE Connectivity. Please be advised that TE Connectivity never requests payment or fees from job applicants at any stage of the recruitment process. All legitimate job openings are posted exclusively on our official careers website at te.com/careers, and all email communications from our recruitment team will come only from actual email addresses ending in @te.com. If you receive any suspicious communications, we strongly advise you not to engage or provide any personal information, and to report the incident to your local authorities.
