Engineer III QA

Work Schedule

Environmental Conditions

Job Description

At 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 COVID19 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 fastgrowing 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.

Join Thermo Fisher Scientific Inc. as an Engineer III QE and play a vital role in maintaining compliance and quality for our brandnew laboratory equipment. These innovative products impact education research and medical discoveries worldwide improving lives every day.

What sets this opportunity apart

Job Responsibilities

• Facilitate and participate in customer internal and thirdparty audits.
• Author review and approve documents such as SOPs PFMEAs and other documentation.
• Investigate supplied component issues understanding drawings specifications PPAP documentation and quality fields to approve robust manufacturing processes.
• Perform trending and evaluation of PNs or equivalent experience deviations and CAPA ensuring their completion.
• Facilitate quality department process improvements and projects.
• Support the validation function by assisting with validation documentation performing qualification protocols and compiling data.
• Perform quality review and approval of procedures training documents and forms of moderate to high complexity.
• Lead and participate in CAPA investigations.
• Lead multifunctional team members supporting the Customer Complaint Process.
• Complete risk and impact assessments.
• Directly contact customers and internal groups.
• Drive product and process changes to improve product quality.

Requirements

• Bachelors degree in engineering field or 5 years of direct Quality Engineering experience; OR Masters degree in Engineering field with 3 years of meaningful experience.
• Demonstrated ability with Quality Management Systems.
• 5 years of handson manufacturing experience leading investigation processes including CAPA NCM complaints and root cause investigations.
• Experience in a regulated environment (e.g. ISO 13485:2016 21 CFR 820 MDSAP).

Knowledge Skills Abilities

• Strong understanding of cGMP GDP and ISO 13485:2016 and 21 CFR 820 requirements.
• Innovative thinking and problemsolving skills using Quality tools such as 8D A3 5Why.
• Outstanding focus on detail and ability to identify and resolve compliance issues.
• Highly effective verbal and written communication skills.
• Selfmotivated proactive and capable of rigorously adhering to deadlines.
• Ability to work well under pressure and multitask optimally.
• Understanding of manufacturing processes product assembly metal forming inspection and controls.
• Excellent interpersonal organizational and influencing skills.
• Skilled in using Microsoft software applications: Word Excel Visio Teams.
• ASQ certification is desired.