Job Description
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 -Minimum 3 days a week on site
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.