Quality Engineer III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As a Quality Engineer III, you'll help ensure quality excellence and regulatory compliance across manufacturing operations. You'll help ensure our products meet the highest standards while supporting our mission to enable customers to make the world healthier, cleaner and safer. This role combines technical expertise with quality oversight to maintain robust quality management systems, lead investigations, support process validation and remediation activities, drive continuous improvement, and ensure GMP/ISO compliance.

You'll work with multiple teams to resolve quality issues, conduct risk assessments, manage CAPAs, support validation and remediation programs, support audits, and implement quality initiatives. The role requires strong analytical and communication skills to interface effectively with internal teams and external customers/regulators. You'll help establish and maintain quality standards while supporting a culture of continuous improvement and compliance.

This position is based in Middletown, VA. Relocation assistance is not provided.

REQUIREMENTS:

Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in quality assurance within a regulated industry, such as pharmaceutical, medical device, or biotech

Preferred Fields of Study: Engineering, Life Sciences, Chemistry, or related technical field

ASQ certifications (CQE, CQA) desired

Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, EMA, etc.)

Experience with process validation , including protocol execution, process qualification, continued process verification, and validation deviation management

Experience leading quality and compliance remediation, including gap assessments, corrective actions, effectiveness checks, and remediation plans

Expertise in quality systems, including:

CAPA and deviation management

Change control

Risk management and FMEA

Document control

Internal and external auditing

Advanced problem-solving and root cause analysis skills

Excellent project management skills

Strong verbal and written communication skills

Proficiency with quality management software and MS Office

Experience with equipment, process, and cleaning validation

Knowledge of statistical analysis, process capability, trending, and quality tools

Ability to work independently and collaboratively

Strong attention to detail and broad perspective

Excellent cross-functional collaboration skills

May require up to 25% travel

Additional language skills may be beneficial

Must be able to satisfy applicable pre-employment screening requirements for the position.

Compensation and Benefits

The salary range estimated for this position based in Virginia is $75,800.00–$113,675.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards