Quality System Specialist

Description:

• A typical day for the candidate involves actively supporting Quality Operations through a mix of hands-on floor engagement and strategic oversight. They begin the day by attending Tier 2 Gemba meetings and providing real-time support to manufacturing teams, ensuring compliance with quality standards.
• Their responsibilities include performing batch record reviews and product releases, reviewing and approving stability studies and labeling (such as FAI and field bulletins), and offering guidance on regulatory standards. The candidate also ensures training compliance, chairs Material Review Board (MRB) meetings, participates in Environmental Control Meetings, coordinates Quality Notifications (QNs), supports internal and external audits, and updates quarterly quality metrics.
• This role requires strong collaboration, attention to detail, and the ability to lead and influence cross-functional teams to uphold product and...