Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Able to lift 40 lbs. without assistance, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

At 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.

• Facilitate and participate in customer, internal, and third-party 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 multi-functional 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.

• Bachelor's degree in engineering field or 5 years of direct Quality Engineering experience; OR Master's degree in Engineering field with 3 years of meaningful experience.
• Demonstrated ability with Quality Management Systems.
• 5 years of hands-on 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).

• Strong understanding of cGMP, GDP, and ISO 13485:2016 and 21 CFR 820 requirements.
• Innovative thinking and problem-solving skills using Quality tools such as 8D, A3, 5-Why.
• Outstanding focus on detail and ability to identify and resolve compliance issues.
• Highly effective verbal and written communication skills.
• Self-motivated, 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.