This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
The Quality Specialist II plays a critical role in supporting Quality Operations through a combination of hands-on manufacturing floor engagement and strategic quality oversight. This position partners closely with Manufacturing, Regulatory, and cross-functional teams to ensure products and processes meet internal quality standards and applicable regulatory requirements. The role requires strong attention to detail, sound judgment, and the ability to influence quality outcomes in a regulated environment.
Job Responsibility:
Support daily Quality Operations by attending Tier 2 Gemba meetings and providing real-time quality guidance to manufacturing teams
Perform batch record reviews and support product release activities
Review and approve stability studies, labeling documentation, FAIs, and field bulletins
Ensure training compliance and maintain quality documentation in regulated systems
Chair Material Review Board (MRB) meetings and coordinate nonconformance investigations and Quality Notifications (QNs)
Participate in Environmental Control Meetings and support contamination and process control initiatives
Support internal and external audits, including audit readiness and response coordination
Compile, analyze, and update quarterly quality metrics and reports
Collaborate cross-functionally to identify root causes, implement corrective actions, and mitigate quality risks
Requirements:
Associate degree or equivalent in Biology, Chemistry, or a related scientific field
2 years of experience in a regulated manufacturing environment, or an equivalent combination of education and experience
Working knowledge of GMP and quality system standards (ISO 13485, FDA 21 CFR 820/210/211)
Experience with device, drug, or biotech manufacturing processes
Hands-on experience with nonconformance investigations, deviation management, batch record review, and product release
Proficiency with QMS databases, SAP, Veeva, and Microsoft Office
Strong attention to detail, organization, time management, and communication skills