Job Description
The Quality Engineering (QE) and Events (NC/CAPA) Manager oversees the development, implementation, and continuous improvement of the company’s quality systems and the intake, evaluation, processing, and closure of all quality events within an OTC pharmaceutical and cosmetic manufacturing environment. This role manages the full lifecycle of nonconformances (NCs), deviations, Corrective and Preventive Actions (CAPAs) and risk management, ensuring timely intake documentation, investigation, root cause analysis, and effectiveness verification. The manager also develops and maintains company‑wide quality performance metrics and dashboards, providing visibility into trends, risks, and improvement opportunities. This position ensures compliance with FDA OTC regulations, 21 CFR 210/211, 21 CFR 701/740, ISO 22716, and internal quality system requirements while fostering a culture of quality and operational excellence.
Quality Specific Responsibility
Ensure all operations are conducted in compliance with applicable regulatory requirements, Good Manufacturing Practices (GMP), and company quality standards. All Hydrox Laboratories Supervisors and Managers are responsible for understanding, implementing, updating and maintaining adherence to Standard Operating Procedures (SOPs), ensuring employees follow approved procedures, and promptly addressing or reporting any deviations from established quality or regulatory requirements.
Every leader is accountable for maintaining a culture of quality and ensuring Hydrox standards consistently meet or exceed both internal expectations and customer requirements.
Duties & Responsibilities
· Lead the intake, triage, and processing investigation and closure of all quality event types, including nonconformances, deviations, and CAPAs.
· Ensure timely authoring, review, approval, closure and lifecycle management of NC and CAPA records.
· Own, oversee and drive root cause analysis, corrective action planning, effectiveness verification and risk management systems.
· Develop, maintain, and publish quality performance metrics and dashboards for leadership review.
· Ensure compliance with OTC drug GMPs, cosmetic GMPs, and internal quality procedures.
· Collaborate with cross‑functional teams to drive timely investigations and sustainable corrective actions through the use of an MRB (Management Review Board).
· Support internal and external audits and related NCs, CAPAs, and quality system performance by providing documentation and subject matter expertise.
· Identify systemic issues and lead cross-functional continuous improvement initiatives.
· Oversee quality system event elements in NCs, deviations, CAPAs, change control, document control, and risk management.
· Train employees on quality system processes, investigation techniques, risk management and documentation expectations.
· Receive and log quality events in the event management system, ensuring proper categorization and assignment.
· Author, review, and approve NC and CAPA documentation, including investigation summaries, root cause analysis and action plans utilizing the electronic event management system.
· Facilitate cross‑functional investigation meetings to ensure thorough root cause analysis and timely resolution.
· Apply structured problem‑solving tools such as 5 Whys, Fishbone, and FMEA and fault tree analysis.
· Track CAPA progress, follow‑up actions, and due dates to ensure timely closure and to ensure compliance with timelines.
· Conduct effectiveness checks to confirm corrective actions prevent recurrence.
· Create and maintain KPI dashboards, including NC aging, CAPA cycle time, recurrence rates, audit findings, and quality trends analysis.
· Present quality metrics to leadership and recommend improvement strategies.
· Support audit preparation and provide documentation during regulatory, customer or internal audits.
· Maintain SOPs related to NC, deviation, CAPA and quality system processes.
· Identify opportunities to streamline workflows and improve quality system efficiency.
· Facilitate cross‑functional management review board (MRB) meetings and maintain alignment across departments.
Knowledge, Skills and Abilities
· Understanding of OTC drug regulations, including 21 CFR 210/211/330, OTC monographs, and drug listing requirements.
· Knowledge of cosmetic GMPs, including ISO 22716 and labeling requirements under 21 CFR 330/701/740.
· Deep familiarity with quality systems, including NC, deviation, CAPA, Change Control, Document Control and Risk Management processes.
· Knowledge of root cause analysis methodologies and structured problem‑solving tools.
· Understanding of manufacturing processes for OTC topicals, skincare, haircare, and cosmetic products.
· Knowledge of quality metrics, dashboard creation, and data trending for performance monitoring
· Familiarity with risk‑based approaches such as FMEA, HACCP, and ICH Q9.
· Strong analytical and problem‑solving skills with the ability to identify root causes and systemic issues.
· Excellent technical writing skills for investigations, CAPA documentation, and quality reports and FMEA.
· Ability to manage multiple quality events simultaneously while maintaining accuracy and compliance.
· Strong communication and facilitation skills for cross‑functional collaboration.
· High attention to detail and strong organizational skills.
· Proficiency with quality management systems and data visualization tools (e.g., Power BI, Excel).
· Ability to interpret and apply regulatory requirements to daily operations.
· Comfortable presenting data and trends to leadership teams.
· Strong analytical and problem‑solving skills with the ability to identify root causes and systemic issues.
· Ability to lead and influence teams without direct authority
· Familiarity with FDA inspections and customer audits.
Qualifications
· Bachelor’s degree in Life Sciences, Chemistry, Biology, Quality Management, or a related field. Equivalent experience will be considered in lieu of degree.
· 4+ years of experience in quality assurance within Medical Device, Pharmaceutical, OTC or cosmetic manufacturing.
· Demonstrated experience managing NCs, deviations, and CAPAs and quality system elements.
· Experience with root cause analysis tools and structured problem‑solving methodologies.
· Experience developing KPIs and dashboards for quality performance monitoring.
· Certifications such as ASQ CQA, CQIA, Six Sigma, or CAPA Investigator Training are beneficial.
Working Condition
The Quality Engineering & Events NC CAPA Manager works primarily in an office environment within an OTC FDA-regulated manufacturing facility, with regular interaction in production, laboratory, warehouse, and quality operations areas. The role requires frequent communication with cross-functional teams including Production, Quality, Regulatory, Engineering, Maintenance, and Supply Chain personnel to support investigations, nonconformance management, CAPA activities, and continuous improvement initiatives.
The position involves regular exposure to manufacturing environments where varying temperatures, noise levels, chemical odors, moving equipment, and production activities may be present. Appropriate personal protective equipment (PPE) must be worn when entering designated manufacturing, warehouse, or laboratory areas in accordance with company safety policies and FDA/GMP requirements.
Physical requirements include the ability to sit for extended periods, work at a computer, communicate effectively, walk through production and warehouse areas, and the ability to lift or move items weighing up to 25 pounds. The role may require extended hours during investigations, audits, regulatory inspections, product quality events, or critical CAPA activities to ensure timely resolution and compliance with company and FDA requirements.
Pay: $100,000.00 - $120,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee discount
- Health insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Work Location: In person
