Quality Assurance Specialist
4 days ago
At Teleflex, we are seeking a highly skilled Quality Engineer III, Design Assurance to join our team. This role is responsible for ensuring quality throughout design transfer and commercialization and sustaining projects.
The Quality Engineer III, Design Assurance will partner with cross-functional teams to ensure product design and manufacturing processes are fully compliant with quality standards and regulatory requirements. This includes coordinating and supporting process validation activities, reviewing and approving process validation protocols and reports, and ensuring compliance of all practices to the Quality Management System.
The ideal candidate will have a strong understanding of industry regulations such as ISO 13485, ISO 14971, and FDA 21CFR820. They will also have excellent analytical and critical thinking skills, as well as strong organizational and time management skills to meet deadlines while managing multiple projects.
We offer a dynamic and growing team environment that provides opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.
- Partner with cross-functional teams to ensure product design and manufacturing processes are fully compliant with quality standards and regulatory requirements.
- Coordinate and support process validation activities, including OQ/PQ.
- Review and approve process validation protocols and reports.
- Ensure compliance of all practices to the Quality Management System.
- Assist with root cause analysis of identified issues and identify appropriate corrective and preventive action.
- Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
Requirements:
- B.A. or B.S. degree in a technical discipline, such as engineering or science.
- 5 to 10 years of quality engineering or design assurance experience, preferably in the medical device industry.
- ASQ certification preferred.
What We Offer:
- A dynamic and growing team environment.
- Opportunities for professional growth and development.
- A comprehensive benefits package.
How to Apply:
Please submit your resume and cover letter to us. We look forward to hearing from you.
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