Project Quality Engineer at NewTec improving safety - critical development processes for industries like Automotive and Medical Technology. Collaborating with engineering teams to ensure quality standards are met.
About the role
- Senior Director of Quality Assurance and Regulatory Affairs at Onnit Labs, leading compliance efforts for dietary supplement products while collaborating across departments.
Responsibilities
- Serve as the primary system administrator for the eQMS, managing user roles, permissions, workflows, and system access.
- Manage controlled documents (SOPs, policies, specifications) within the eQMS and oversee document creation, review, approval, version control, and archiving.
- Facilitates and organizes training matrix as well as training documents for employees on SOPs, documents, forms and GMPs and ensure company-wide compliance training is up to date.
- Oversee product complaints, including Adverse Event (AE) tracking, investigation, and reporting.
- Log and track non-conformances, deviations, and CAPA activities; monitor progress to ensure timely completion and effectiveness checks, analyze trends, and escalate recurring issues as necessary.
- Conduct internal audits and support third-party, FDA, and regulatory inspections.
- Generate and analyze quality KPIs and trends and present quality data for management reviews and continuous improvement initiatives.
- Collaborate with R&D, Product Development, Marketing, Legal, and Operations to support product innovation and go-to-market strategies.
- Advise executive leadership on quality and regulatory risks and opportunities.
Requirements
- Develop and deliver training on eQMS usage, GMP, and quality processes to internal users
- Lead the incident management process, ensuring timely identification, investigation, resolution, and documentation of quality-related events.
- Strong understanding of FDA regulations (21 CFR Part 111/117) and GMP requirements
- Proficiency in Microsoft Office; familiarity with data visualization tools a plus
- Experience with eQMS platforms
- HACCP, PCQI certifications (optional, but preferred)
- Experience with FDA inspections
Benefits
- Full medical, dental, and vision benefits
- Basic Life Insurance
- Immediate 401(k) eligibility with company matching
- Unlimited vacation
- Paid holidays
- Flexible workplace policy
- $100/month flexible benefit stipend
- Tuition reimbursement
- Fringe benefits include in-office meals, product credits and discounts, lifestyle spending account, family planning, online learning, fitness stipend, among many others
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