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Quality Systems Analyst
hace 2 meses
At Te Connectivity, you will have the opportunity to work with a diverse team of professionals to create innovative solutions for a safer, more connected world.
Key Responsibilities:- Quality Systems Lead: Ensure that all quality-related activities are performed in accordance with our Quality Management System (QMS) procedures.
- Quality Representative: Collaborate with management to ensure the relevance of our Quality Policy and Quality Objectives.
- Quality Assurance Specialist: Work with management to ensure that the proper resources are available to conduct QMS activities.
- Non-Conformance, Complaint, and Corrective Action (NCR, CAPA) Management: Oversee the NCR, Complaint, and CAPA systems to ensure proper disposition of non-conforming materials, root cause determination, and corrective/preventive actions.
- Supplier Evaluation and Management: Evaluate suppliers for their ability to provide needed materials/services, including supplier audits.
- Instrumentation and Equipment Management: Manage instrumentation and equipment used for inspections and verification and validation (V&V) activities.
- Record Management: Maintain records needed to demonstrate conformance to standards.
- Quality Management Reviews: Conduct Quality Management Reviews to ensure the effectiveness of the QMS in accordance with ISO 13485 standards and applicable regulatory requirements.
- Document Control: Perform document control activities to ensure the most current revisions are available while segregating and storing previous revisions.
- Internal Audit Participation: Participate in the Internal Audit program.
- External Audit Support: Act as a Quality Representative during external audits (customer and notified bodies).
- Quality Culture Promotion: Promote quality as a culture throughout the site and the organization.
- Collaboration and Communication: Work collaboratively across site functions and with all levels of the organization.
- New Product Development Support: Consult on new product development projects regarding quality-related questions and ensure that project documents are managed properly.
- Verification and Validation Support: Support Verification & Validation and Design Transfer activities.
- Process Development Support: Collaborate with manufacturing/operations to develop receiving inspections, in-process inspections, and final acceptance testing for process development projects.
Bachelor's Degree and minimum 5 years of related work experience (Master's Degree preferred). Experience working in a team environment. Current working knowledge of ISO 13485 Quality Management Systems and FDA 21 CFR 820 strongly preferred. Strong MS Excel and Word experience. Excellent analytical skills. Ability to communicate effectively and work individually and in a team environment.
Competencies and Values:Integrity, Accountability, Inclusion, Innovation, Teamwork
