Join a leader in medical device research, innovation, and customer service as a Quality Manager in Portsmouth, NH! This full-time, direct-hire position requires someone with prior experience managing the QA process from supplier qualification and audits to managing internal audits. Put your passion for managing the QC process to work at a business voted one of the most ethical companies for over 15 years!
Responsibilities of the Quality Manager
- Develop, implement, communicate, and maintain effectiveness of a quality system that is in compliance with FDA QSR and ISO 13485 standards
- Manage and maintain the quality inspection and product release programs
- Set QA objectives for the review and approval of top management, and ensure that targets are achieved
- Participate in new product development activities to ensure proper QA can be implemented prior to beginning manufacturing
- Ensure supplier corrective actions are timely and effective
- Track and report significant quality deviations
- Develop and maintain an effective quality systems and regulatory affairs training program for all appropriate business associates
- Develop, edit, review, and approve validation protocols and reports
- Develop strategies, draft responses, and/or review responses and documents intended for submission to regulatory agencies
- Provide business-sensitive regulatory advice
Qualifications of the Quality Manager
- 5+ years of quality assurance experience including 2+ years of supervisory leadership
- Strong verbal and written communication skills
- ISO and FDA quality systems knowledge
- Bachelor’s degree in Science or Management preferred
- Medical device manufacturing experience desirable
- Ability to ensure and develop effective QA systems
- Experience with ISO 13485 Audit and Regulatory Compliance preferred
If you share our client’s commitment to doing the right thing and ensuring a cleaner, more beautiful world for generations to come, apply today for this Quality Manager position!
About Leddy Group
We are a privately owned, regional staffing company serving northern New England since 1994. We put the right people in the right places through our specialties: Accounting & Finance, Administrative & Customer Service, Engineering, HR, Industrial and Skilled Manufacturing. We combine a consistency of values and traits with a singular standard for quality and best practices. Our goal is to exceed your expectations; our success is tied directly to your satisfaction.