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
TE Connectivity's Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication.
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- Work with the Supervisor and manufacturing engineering to promote health and safety goals.
- Deliver on all KPIs to help the business achieve its goals.
- Perform an active role in the development and continuous improvement of the quality management system.
- Perform validations and revalidations on equipment and processes; write necessary protocols.
- Compile validation and revalidation reports.
- Evaluate and establish validation requirements for new or changed processes, equipment, materials, or formulations.
- Establish and maintain risk management principles and methods in compliance with the company's Quality Management system and ISO 14971.
- Maintain relevant documentation to comply with quality standards and customer requirements.
- Offer quality guidance to Quality Technicians to support day-to-day manufacturing operations.
- Develop strong links with customer organizations and project stakeholders.
- Conduct quality reviews of responsible area validation documentation.
- Investigate root causes and implement effective corrective actions to prevent recurrence of compliance issues.
- Hold overall responsibility for production GMP standards and compliance.
- Establish inspection standards, sampling plans, and test methods.
- Prepare and update operations procedures and associated documentation.
- Conduct audits of manufacturing operations and the Quality system for ISO 13485 compliance.
- Support operations area projects and initiatives, e.g., Kaizen, data analysis, problem-solving tools.
What your background should look like:
- Degree in Quality or Degree in Science / Engineering.
- Experience within a similar role as quality engineer.
- 2+yrs of quality engineering experience preferably in the medical device-manufacturing or pharmaceutical environment.
- Working knowledge of FDA/ISO/MDD Quality systems for medical device companies.
- Quality experience in component and device manufacturing desirable.
- Excellent written and oral communication skills essential.
Competencies
Values: Integrity, Accountability, Inclusion, Innovation, Teamwork
ABOUT TE CONNECTIVITY
TE 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: $89,600- 134,000 (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) + 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