Staff QA Engineer

Work Schedule

Environmental Conditions

Job Description

Staff QA Engineer

• Site Based Role
• Oakwood Village OH (just outside of Cleveland)

At the Thermo Fisher Scientific team youll 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 outstanding 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 an exciting career with us.

Location/Division Specific Information

Chemical 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 Ohio

Discover 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
• 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