Quality Engineer:
About The Position
Reporting to the Senior Director of Quality, the Quality Engineer is responsible for driving quality system improvements through data analysis, risk assessment, validation support, and root cause investigation activities. This role partners cross-functionally with QA, QC, Manufacturing, Engineering, and Operations to improve process capability, reduce quality risk, and strengthen compliance within a regulated manufacturing environment. The Quality Engineer supports continuous improvement initiatives by analyzing trends, identifying systemic issues, implementing corrective actions, and supporting validation and process improvement projects. This position plays a key role in enhancing operational efficiency, product quality, and overall Quality Management System (QMS) effectiveness.
Requirements
- Bachelor’s degree in Engineering, Chemistry, Life Sciences, or related technical field
- 3+ years of experience in Quality Engineering, Quality Systems, Manufacturing Engineering, or Quality Assurance within a regulated manufacturing environment
- Strong knowledge of GMP requirements and quality systems
- Experience with root cause analysis, CAPA, deviations, and change control processes
- Experience supporting validation activities and risk assessments
- Strong analytical, problem-solving, and organizational skills
- Ability to analyze and trend data to identify process improvement opportunities
- Strong written and verbal communication skills
- Ability to manage multiple projects and priorities in a fast-paced environment
Nice To Haves
- Experience in OTC, pharmaceutical, cosmetic, or personal care manufacturing
- Experience with validation protocols and equipment qualification activities
- Familiarity with eQMS systems, ERP systems, and manufacturing data systems
- Knowledge of Lean Manufacturing, Six Sigma, or continuous improvement methodologies
- Experience supporting audits and regulatory inspections
- Understanding of data integrity principles and risk management tools (FMEA, 5 Whys, Fishbone Analysis)
Responsibilities
- Lead and support root cause investigations related to deviations, NCRs, CAPA, and process failures
- Analyze quality and manufacturing data to identify trends, recurring issues, and opportunities for process improvement
- Support implementation and effectiveness verification of corrective and preventive actions (CAPA)
- Perform risk assessments related to manufacturing processes, quality events, and process changes
- Support validation activities, including process validation, equipment qualification, and cleaning validation
- Partner with Manufacturing, QA, QC, and Engineering teams to improve process capability and operational efficiency
- Develop and track quality metrics, trend reports, and continuous improvement initiatives
- Support change control activities by evaluating process and quality impacts
- Assist with development and improvement of procedures, workflows, and quality system documentation
- Participate in internal audits, inspection readiness activities, and regulatory support initiatives
- Support implementation of data-driven process improvements and risk mitigation strategies
- Perform additional duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Senior
