Senior Quality Assurance Engineer – Jaffrey, NH

Teleflex Medical OEM specialties, an $800 million dollar global medical and surgical device manufacturer, is seeking a Senior Quality Assurance Engineer for our Jaffrey, New Hampshire location. This position will provide technical support and take a leadership role in quality engineering functions in manufacturing and product development in compliance with FDA 21CFR Part 820, ISO 13485, and internal procedures.
REQUIREMENTS
Responsibilities include:
- Direct quality activities in manufacturing such as inspection methods and Material Review Board (MRB)
- Support product development such as design change and review, quality planning, risk evaluation, and validation.
- Supervise Quality Assurance Inspectors as needed.
- Coordinate Corrective and Preventive Action (CAPA) for customer, internal, and vendor related needs.
- Audit internal and vendor processes and procedures.
- Participate in Continuous Improvement Projects (CIP) and Six Sigma for both processes and business systems.
- Develop training programs for inspection and engineering.
- Represent company during customer or regulatory audits as needed.

Education
Bachelor of Science degree required; ASQ certification highly desired

Work Experience
- Minimum 7-8 years QA engineering experience in a manufacturing environment.
- Regulatory cGMP, QSR and ISO knowledge base
- Computer proficient (MS Word, Excel, Access, PowerPoint, and Mini-tab preferred)
- Statistical skills (DOE, SPC, Reliability, Gage R&R)
- Experience with risk analysis methodologies
- Experience in the area of manufacturing operations
- Validation concepts & techniques (process, equipment, and gauging)
- Experience developing training programs

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