Quality Engineer III
About The Position
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.
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
- 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
- Must be able to satisfy applicable pre-employment screening requirements for the position.
Nice To Haves
- Preferred Fields of Study: Engineering, Life Sciences, Chemistry, or related technical field
- ASQ certifications (CQE, CQA) desired
- Additional language skills may be beneficial
Responsibilities
- Ensure quality excellence and regulatory compliance across manufacturing operations.
- Ensure products meet the highest standards.
- Maintain robust quality management systems.
- Lead investigations.
- Support process validation and remediation activities.
- Drive continuous improvement.
- Ensure GMP/ISO compliance.
- Work with multiple teams to resolve quality issues.
- Conduct risk assessments.
- Manage CAPAs.
- Support validation and remediation programs.
- Support audits.
- Implement quality initiatives.
- Establish and maintain quality standards.
- Support a culture of continuous improvement and compliance.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
