Supervisor, Final Release- Night Shift

The Supervisor, Final Release
-Night Shift provides day-to-day leadership and supervision of the Final Release team, ensuring manufacturing records, documentation, inspections, and final release activities are completed accurately, efficiently, and in accordance with established procedures, customer requirements, and applicable quality and regulatory standards.

This role is responsible for setting daily operational priorities, assigning work, monitoring workflow and schedules, reviewing team output, and ensuring policies, procedures, and quality requirements are consistently understood and followed. The Supervisor works closely with Operations, Program Management, Engineering, Customer Service, Distribution, and other cross-functional partners to address documentation or release issues and support on‑time product release.
The supervisor of Night Shift is 5‑day on‑site role which will cover
Monday through Friday 3pm - 11pm.

• Provide direct, day-to-day supervision of the Final Release team, including assigning tasks, establishing priorities, monitoring work in progress, and ensuring daily schedules and commitments are achieved.
• Set daily operational objectives and communicate priorities, workload expectations, and changes to the team.
• Monitor individual and team performance, provide timely coaching and feedback, and ensure employees understand and follow established policies, procedures, and work instructions.
• Coordinate staffing and workload based on production priorities, release requirements, and business needs.
• Train and support team members on Final Release processes, documentation requirements, quality systems, and established procedures.
• Escalate employee performance, resource, quality, or operational issues to Quality management as appropriate.

• Oversee the flow of manufacturing and technical records through the Final Release process, ensuring records are properly prepared, reviewed, inspected, and completed.
• Assign and track work-in-progress records through completion and final disposition.
• Ensure timely and accurate Quality Assurance review of data entry, manufacturing documentation, technical records, Device History Records (DHRs), batch records, and final release documentation and generate CFC.
• Ensure each batch or product is inspected against applicable specifications and that physical product verification is completed before final disposition.
• Ensure records comply with applicable SOPs, customer requirements, accreditation standards, and regulatory requirements.
• Review documentation for completeness and accuracy and coordinate correction of missing, incomplete, or inaccurate information.
• Ensure Quality variances, documentation errors, deviations, and nonconformances are appropriately identified, initiated, documented, and escalated.
• Support the tracking of nonconformances, deviations, and CAPAs through appropriate Quality processes.
• Maintain knowledge and effective use of ERP, QMS, and other applicable electronic systems.

Cross-Functional Collaboration

• Represent Quality/Final Release in production planning and prioritization meetings.
• Communicate release status, documentation gaps, risks, and other issues that may impact schedules.
• Work with appropriate stakeholders to resolve routine and moderately difficult workflow, documentation, or release issues within established policies and procedures.
• Escalate issues requiring decisions outside established processes or the Supervisor’s authority.

Process Compliance & Continuous Improvement

• Ensure the Final Release team consistently follows approved standard operating procedures and controlled work instructions.
• Support the development and maintenance of controlled Final…