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Company

Original Job Post

Thermo Fisher Scientific · 2 days ago

Manager, QA

Cleveland, OH

Full-time

Onsite

Senior Level

5+ years exp

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BioinformaticsBiotechnology

H1B Sponsorship

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Responsibilities

Leads and maintains Quality Systems, including ISO 9001, ISO 17025, 10 CFR, and associated internal audit programs

Ensures timely periodic reviews and updates to the document management system.

Supports all functional departments to ensure integrity of the Quality Systems and compliance to all applicable regulations.

Measure and drive enhancements of Core QA processes (CAPA, Complaints, Quarantine, Recall, Internal Audit etc.)

Collaborates with Portfolio Management for new and existing product issue prioritization, including customer complaints and product recalls.

Develops and maintains written procedures, work instructions and/or manuals for each area of responsibility.

Responds in a timely manner to all correspondence from business partners, global quality, regulatory and champions standard processes with them.

Leads site quality team including Quality Engineers and Technicians

Implements strong quality systems that provide controls as defined by regulatory, marketplace and our customers.

Qualification

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Quality AssuranceCross-Functional Teams ManagementProblem-SolvingLeadership

Required

Bachelor of Science Degree in Chemistry, Bio-Chemistry, Biology, Engineering, or Applied Sciences

+5 years of experience working in fields such as medical device manufacturing, healthcare, pharmaceutical, chemicals, or high volume manufacturing

+5 years of related experience in leading the mechanisms vital for effective operational execution of a quality assurance organization

Managing cross functional teams to solve complex technical issues

Benefits

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Designated Paid Holidays

401K

Tuition Reimbursement

Employee Referral Bonus

Career Advancement Opportunities

Company

Thermo Fisher Scientific

Glassdoor

3.6

Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

Founded in 1956

Waltham, Massachusetts, USA

10,001+ employees

http://www.thermofisher.com

H1B Sponsorship

Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (173)

2022 (314)

2021 (349)

2020 (251)