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Quality Systems Analyst
hace 2 meses
The Quality Systems Analyst will serve as the Quality Systems Representative for Te Connectivity, ensuring that all quality-related activities are performed according to the Quality Management System (QMS) procedures. This role requires a working knowledge of Quality Assurance and Quality Control principles.
Key Responsibilities- Collaborate with management to ensure the relevance of the Quality Policy and Quality Objectives.
- Oversee Non-Conformance Reports (NCR), Complaint, and Corrective Action Preventive Action (CAPA) systems to ensure proper disposition of non-conforming materials and root cause determination.
- Evaluate suppliers for their ability to provide needed materials and services, including supplier audits.
- Manage instrumentation and equipment used for inspections and verification and validation (V&V) activities.
- Maintain records needed to demonstrate conformance to standards.
- 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 to ensure the most current revisions are available while segregating and storing previous revisions.
- Participate in the Internal Audit program.
- Act as a Quality Representative during external audits (customer and notified bodies).
- Promote quality as a culture throughout the organization.
- Work collaboratively across site functions and with all levels of the organization.
- Consult on new product development projects regarding quality-related questions and ensure that project documents are managed properly.
- Support Verification & Validation and Design Transfer activities.
- 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.
- Ability to work individually and in a team environment.
