Quality Engineering Manager

2 weeks ago


Asheville, North Carolina, United States Thermo Fisher Scientific Full time
About Us
At Thermo Fisher Scientific, we are committed to working the right way, for the right reasons, with the customer always top of mind. We empower our colleagues to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions.

Job Summary
We are seeking a highly skilled Quality Engineering Manager to lead our quality team and drive product and process changes to improve product quality. This role will involve facilitating customer, internal, and third-party audits, authoring, reviewing, and approving documents, and performing trending and evaluation of PNs or equivalent experience. The estimated salary for this position is $140,000 - $180,000 per year, depending on location and qualifications.

Key Responsibilities
The successful candidate will have 7+ years of direct Quality Engineering experience, with a strong understanding of cGMP, GDP, and ISO 13485:2016 requirements. They will lead multi-functional team members supporting the Customer Complaint Process, complete risk and impact assessments, and directly contact customers and internal groups. They will also have experience in a regulated environment, such as ISO 13485:2016, 21 CFR 820, and MDSAP.

Requirements
To be successful in this role, you will need to demonstrate ability with Quality Management Systems, possess strong innovative thinking and problem-solving skills, and have excellent verbal and written communication skills. You will also require knowledge of manufacturing processes, product assembly, metal forming, inspection, and controls, as well as proficiency in Microsoft software applications such as Word, Excel, Visio, and Teams.

What We Offer
We offer a comprehensive benefits package, including competitive pay, paid time off, and opportunities for professional growth and development. We are an EEO/Affirmative Action Employer and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

Benefits Summary:
  • Competitive salary: $140,000 - $180,000 per year
  • Paid time off and holidays
  • Comprehensive benefits package
  • Opportunities for professional growth and development


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