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Manager - QA

2 months ago

New Bedford, Massachusetts, United States Thermofisher Scientific Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information:

This opportunity is located at our Oakwood Village, OH facility near Cleveland within the Chemical Analysis Division (CAD). This site produces a variety of radiation detection equipment.

The Chemical Analysis Division (CAD) provides a diverse mix of analytical instruments and associated services to a broad range of end user markets including Safety & Security, Environmental, Food Safety, Energy, Mining, Life Science Manufacturing and Recycling, to name a few. Its instruments are deployed in the field and on the line, in challenging environments where customers put a premium on robustness, reliability and ease of use. They allow them to make decisions where they operate and streamline their businesses. CAD is a complex division with a global footprint, broad product portfolio and diverse customer base.

How Will You Make an Impact?:

We are looking for a dedicated and resourceful Leader with up-to-date knowledge, and shown experience driving and sustaining improvement to Quality Management Systems to ensure compliance to all applicable standards.

This role has a direct influence in building Quality Management System Excellence in our Oakwood Village, OH site and supports revenue growth by delivering an outstanding customer experience.

A Day in the Life:

  • 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.

Education:

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

Experience:

  • +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

Knowledge, Skills, Abilities:

  • Demonstrates flexibility and lead multiple complex projects simultaneously.
  • Excellent oral and written communication skills with the ability to effectively convey business and technical challenges to all levels of management.

Physical Requirements/Work Environment

  • Electronics manufacturing setting with personal protective equipment (PPE) requirements including but not limited to: safety glasses protection and closed toed footwear.
  • Prolonged periods of sitting required.
  • Ability to lift up to 25 lbs unaided.

Compensation

  • Competitive Pay Rate
  • Annual performance-based bonus
  • Annual merit performance-based increase

Excellent Benefits

  • Benefits & Total Rewards | Thermo Fisher Scientific
  • Medical, Dental, & Vision benefits-effective Day 1
  • Paid Time Off & Designated Paid Holidays
  • 401K
  • Tuition Reimbursement
  • Employee Referral Bonus
  • Career Advancement Opportunities

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.