Quality Analyst / Engineer III
Location: Carlsbad, California
Job Type: Full time
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
TE Connectivity's Quality Assurance Teams are responsible for all or part of an organization's Quality Management System, including conformance and continuous improvement initiatives. They work on systemic evaluation of products, services, facilities, manufacturing or business processes, to ensure that standards of quality are being met. Develop and implement quality plans, programs and procedures using quality control statistics, lean manufacturing concepts, and six-sigma tools and analyses. They reviews, analyze and report on quality discrepancies, investigate problems and executes quality audits, and develops disposition and corrective actions for recurring discrepancies. The team works closely with manufacturing, engineering, customers, or suppliers and subcontractors to ensure requirements are met.
The Quality Analyst / Engineer III is the Quality Representative for this location. This role is responsible for ensuring that all quality-related activities are being performed according to the QMS procedures and must have a solid working knowledge of ISO 13485 and FDA 21 CFR 820. They must also be experienced in the medical device industry and have a strong background in device design & development and transfer to manufacturing (TtM).
- Consult on new product development projects regarding quality related questions and ensure that project documents are managed properly
- Support V&V and Design Transfer activities
- Collaborate with manufacturing/operations to develop receiving inspections, in-process inspections, and final acceptance testing for process development projects
- Conduct Quality Management Reviews to ensure the effectiveness of the QMS in accordance with ISO 13485 standards and applicable regulatory requirements
- Perform document control activities ensuring the most current revisions are available while segregating and storing previous revisions
- Participate in the Internal Audit program
- Acts as a Quality Representative during external audits
- Collaborate to ensure the relevance of the Quality Policy and the Quality Objectives
- Work with Management to ensure that the proper resources are available to conduct QMS activities
- Oversee NCR, Complaint, and CAPA systems to ensure proper disposition of non-conforming materials, root cause determination, and corrective/preventive actions
- Evaluate suppliers for ability to provide needed materials/services including supplier audits
- Manage instrumentation and equipment used for inspections and V&V activities
- Maintain records needed to demonstrate conformance to the standards
- Promote quality as culture throughout the site and the organization
- Work collaboratively across site functions and with all levels of the organization
What your background should look like:
- Bachelor’s Degree and minimum 5 years of related work experience
- Experience working in a team environment where few others are experts in quality systems
- Current working knowledge of ISO 13485 Quality Management System and FDA 21 CFR 820
- Strong MS Excel and Word experience
- Excellent analytical skills
- Must continually seek improvement and effect change in the operating systems
- Ability to communicate effectively through email, instant messaging, and verbal methods
- Ability to work individually and in a team environment
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, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications and the home. With approximately 80,000 employees, including more than 7,500 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 and Twitter.
- Competitive base salary commensurate with experience: 80K - 100K (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
- 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