Staff QA Engineer

Oakwood Village, OH
Permanent
Full-time

1 month ago

Work Schedule Standard (Mon-Fri)Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Standing for full shift, WarehouseJob DescriptionJob DescriptionAt the Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.Location/Division Specific InformationChemical Analysis Division (CAD) has innovative analytics, from Lab to Line to Field. The business serves a wide breadth of industrial sectors including pharmaceutical, food and beverage, environmental, process minerals, mining, coal, cement and metals, as well as academic, government, safety, and security. This position will be based in our Oakwood Village site outside of Cleveland, OhioDiscover Impactful Work:The Quality Engineer will report directly to the Quality Assurance Manager. You will play an important role in collaborating with the Operations team to ensure our products achieve the highest level of quality standards. This will involve analyzing non-conformance data, leading corrective action initiatives, supporting software verifications, and working with vendors on improving their products and processes.A day in the Life:

Develop and complete software verification and validation test plans
Guide process improvement teams both internal and external to the company.
Provide technical support to our procurement team for second source and cost reduction activities.
Work effectively with suppliers, purchasing, production, engineering, and customer service as needed.
Hands-on software quality work, particularly in the area of establishing root cause analysis, corrective action, software validation, and SOP creation.

Keys to Success:Education

Bachelor of Science (BS) or Master of Science (MS) from accredited College, University, or equivalent

Experience

Minimum of 7 years of experience with standard quality tools such as 5 Whys, Ishikawa Diagrams, GEMBA walks, etc.
American Society of Quality (ASQ) Certified Quality Engineer (CQE) or equivalent preferred

Knowledge, Skills, Abilities

Experience with software validation, problem solving, and issue management systems (e.g. JIRA)
Knowledge and experience implementing the ISO 9001:2015 standard
Knowledge and experience implementing the ISO 17025:2017 standard
Proven ability to implement new programs and processes with minimal direction
Passionate about quality and process improvement
Ability to implement 8D, or similar, approach for Corrective and Preventative Actions
Experience using quality tools mentioned above applied to the manufacturing of a dosimetry system preferred
Proficient in Microsoft Excel
Ability to write clear and cohesive work instructions to ensure consistency, quality, and safety in task execution

Physical Requirements / Work Environment

Ability to lift/push/pull up to 40 pounds on regular basis
Warehouse environment under varying temperatures
Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time
Visual acuity to use a keyboard, computer monitor, operating equipment, and read materials for prolonged periods of time
Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time

Thermo Fisher Scientific

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