Quality Engineer

About the role

This role is responsible for leading high-quality cGMP investigations, driving root cause elimination, and implementing sustainable corrective and preventative actions (CAPAs). The Specialist will play a critical role in advancing continuous improvement initiatives, enhancing process robustness, and improving process reliability. The ideal candidate combines strong technical writing, analytical problem-solving, and cross-functional collaboration to ensure regulatory compliance, reduce recurring quality events, and support inspection readiness.

Responsibilities

• Lead end-to-end cGMP investigations (deviations, non-conformances, complaints) with a focus on root cause identification, risk mitigation, and prevention of recurrence
• Apply structured root cause methodologies (e.g., 5 Whys, Fishbone, FMEA) to identify systemic issues and drive continuous improvement
• Develop, implement, and track CAPAs, ensuring effectiveness, sustainability, and measurable outcomes
• Analyze and trend data to identify recurring issues and improvement opportunities
• Evaluate and collaborate on cGMP-compliant documentation, including SOPs, production records, studies, validation protocols, and reports
• Initiate and manage change controls in support of process, equipment, and continuous improvement initiatives
• Ensure documentation meets cGMP and FDA regulatory expectations, with a focus on clarity, accuracy, and compliance
• Partner with Manufacturing, Engineering, MSAT, Facilities, Finance and Quality to implement process improvements
• Contribute to inspection readiness by maintaining high-quality investigation and documentation standards
• Lead interdepartmental continuous improvement initiatives

Qualifications

• Bachelor's degree in biology, Chemistry, Engineering, or related scientific discipline
• 5+ years of experience in investigations in a cGMP manufacturing, quality, or continuous improvement role (CMO/CDMO experience preferred)
• Demonstrated experience leading GMP investigations and authoring deviations, non-conformances, complaints, CAPAs, and change controls
• Strong technical writing skills with the ability to translate complex technical information into clear, compliant documentation
• Hands-on experience with root cause analysis tools (5 Whys, Fishbone, FMEA) and data trending/metrics analysis
• Working knowledge of cGMP regulations, FDA expectations, and Quality Systems
• Proven ability to collaborate effectively in a cross-functional, onsite manufacturing environment
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Experience with eQMS/document management systems (MasterControl preferred)
• Experience in a contract manufacturing (CDMO/CMO) environment supporting multiple clients

Schedule

100% On-Site, Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00am and 9:30am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

Pay & Benefits

Pay range: $105,000 - $115,000 annually. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Benefits include: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).