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Senior Quality Engineer - Manufacturing – Base Salary 80k to 105k/year - Auburn, NY
Job Description
Senior Quality Engineer - Manufacturing – Base Salary 80k to 105k/year – Auburn, NY
- Our client, renowned for their innovative and trailblazing approach to shaping future products in the manufacturing industry, is seeking a Senior Quality Engineer to ensure product excellence and optimize manufacturing efficiency.
- In this position, you'll leverage your expertise in manufacturing and software quality engineering to facilitate compliance with industry regulations and Quality Systems requirements while assisting internal stakeholders, customers, and suppliers.
Responsibilities:
- Contribution to the development and execution of regulatory strategies for ongoing development projects, product transfers, and QMS-related matters.
- Supervision of non-conformances, CAPA, complaints, validations, and quality events, ensuring alignment with company policies, international regulations, and guidance, as well as site-specific procedures and requirements.
- Offer expertise in manufacturing and software quality engineering to R&D and Engineering teams, ensuring compliance with ISO, FDA, CMRD regulations, and Quality Systems requirements, including reviewing and approving product life cycle management activities.
- Conduct statistical data analysis, review metrics, and propose enhancements.
- Provide support for internal, external, customer, and supplier audit programs.
- Enhance Quality Management System procedures to align with US and European quality strategies.
- Lead or provide support for activities related to Safety and Risk Management.
Qualifications:
- Bachelor’s degree in a scientific, technical, or business field, along with 5+ years of experience in a manufacturing facility
- Experience in a medical device or other highly regulated industrial environment
- Understanding of ISO 9001 required, ISO 13485 preferred
- Demonstrated understanding and application of Six Sigma, Lean Principles and related methodologies
- Experience with QMS, validation and verification processes, root cause analysis
- Ability to travel internationally between sites and to customers and suppliers (up to 20%)
- Audit experience required
Compensation:
- Base salary in the 80k to 105k/year range
- Medical, Dental, Vision, 401k, Paid Time Off
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Additional Information
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Meet Your Recruiter
Laura McKenney
Professional Recruiter - Manufacturing
Laura brings many years of Recruiting experience to the world class AllSearch Recruiting team.
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