Description:
Lead supplier quality activities to ensure externally supplied materials, components, and services meet GMP, ISO 13485, and internal standards. Support the audit program, CAPA follow-up, and Quality Technical Agreements (QTAs) in partnership with Supplier Owner and cross-functional teams.
Location: Warren, New Jersey - 3 days on site & 2 days remote
Salary Range : 125k-150k
Key Responsibilities:
- Support the audit program: annual plan, execution, reporting, and follow-up of CAPA effectiveness.
- Maintain supplier risk assessment, segmentation, and performance reviews; drive improvement actions with suppliers.
- Lead QTA lifecycle: creation, review, negotiation support with Procurement, and periodic updates; ensure RACI is defined and applied.
- Support SOPs for Supplier Management and ensure alignment with global procedures, coach teams on process adherence.
- Ensure readiness for inspections (e.g., FDA, EU) and PAI: maintain supplier files GMP certificates, monitor expirations, and prepare audit/inspection evidence.
- Provide quality engineering support (incoming controls, sampling plans, problem solving 8D/5Why, data analysis) to prevent recurrence of issues.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, Pharmacy or related field (Master’s preferred).
- Formal auditor training (ISO 13485, GMP) required or equivalent experience; Lead Auditor certification preferred.
- 5–8 years in Supplier Quality/Quality Engineering in medical device and/or pharma. Pharma/Biologics preferred.
- Proven experience leading supplier audits, managing CAPA, and implementing QTAs.
- Working knowledge of FDA 21 CFR Parts 820/210/211/600/610/680, EU GMP, ISO 13485, ISO 14971.
- Experience with eQMS (Veeva or ENNOV is a +), supplier performance dashboards, and RACI implementation.
- Fluent in English; strong communication and stakeholder influencing skills.
Behavioral Skills:
- Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”
- Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions.
- Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals.
- Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.