Quality Assurance Specialist
hace 7 días
Teleflex Incorporated is a global leader in providing medical technology solutions that make a difference in patients' lives. Our Global Operations team is responsible for product fulfillment to all our customers from end to end, with a focus on improving quality, service, and value as perceived by our customers.
Position SummaryThe Quality Engineer III, Design Assurance will be part of a cross-functional team responsible for quality throughout new product development and improvement up to and including technology transfer and commercialization. This role ensures that applicable elements of the Quality System and external standards are followed, applying best-practice quality, team-based, and statistical tools and techniques.
Key Responsibilities- Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process design, including design verification, design validation, design reviews, design transfer, and design history file creation.
- Create and maintain risk files consisting of risk management plans, hazard and risk analyses, failure mode and effects analyses, and risk management reports to assess product risks.
- Analyze post-market surveillance data periodically throughout a product's lifecycle to feed back into its risk file and reflect its current risk profile.
- Ensure compliance of all practices to the Quality Management System, including comprehensive documentation, adequate records, and change management.
- Interpret customer feedback to define user needs and product requirements as part of a cross-functional team.
- Partner with Product Quality Assurance and Operations to make risk-based decisions associated with nonconformances and technical complaints.
- Perform root cause analysis of identified issues and identify appropriate corrective and preventive action using the NC and CAPA systems.
- Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
Bachelor's degree in a technical discipline, such as engineering or science, with 5-10 years of quality engineering or design assurance experience in the medical device industry. ASQ certification preferred. Strong understanding of industry regulations, including ISO 13485, ISO 14971, and FDA 21CFR820. Proficient in MS Office and statistical software. Strong organizational and time management skills, analytical and critical thinking skills, and technical report writing and review skills.
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