Engineer III, QA

Thermo Fisher Scientific - Asheville, NC

Full-time - Mid Level

Asheville, NC

Computer and Electronic Product Manufacturing

About the position

As an Engineer III in Quality Engineering at Thermo Fisher Scientific, you will play a crucial role in ensuring compliance and quality for innovative laboratory equipment. This position involves facilitating audits, authoring and reviewing critical documentation, and leading investigations to resolve quality issues. You will work closely with customers and internal teams to drive product and process improvements, ultimately impacting education, research, and medical discoveries worldwide.

Responsibilities

• 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.

Requirements

• 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.

Nice-to-haves

• ASQ certification is desired.