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Skills
Coachingunmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Cost Controlunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Detail Orientedunmatched
Documentation Planunmatched
ERP (Enterprise Resource Planning)unmatched
Establish Prioritiesunmatched
FDA Requirementsunmatched
GMP (Good Manufacturing Practices)unmatched
Investigative Reportsunmatched
Lean Manufacturingunmatched
Lift/Move 25 Poundsunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Managementunmatched
Manufacturing Operationsunmatched
Medical Equipmentunmatched
Metricsunmatched
Performance Analysisunmatched
Performance Reviewsunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Production Controlunmatched
Production Supportunmatched
Quality Assuranceunmatched
Quality Controlunmatched
Regulatory Complianceunmatched
Resource Managementunmatched
Team Playerunmatched
Warehousingunmatched
Description
Position Summary:
The Manufacturing Supervisor will provide front-line support for Nuclein’s manufacturing operations. The individual will be responsible for overseeing day-to-day manufacturing activities, ensuring compliance with FDA regulations and GMP guidelines, and contributing to continuous improvement initiatives to optimize efficiency and product quality.
Essential Duties and Responsibilities:
Front-line support for Nuclein’s manufacturing operations, ensuring adequate resources, manufacturing capacity and planning as well as assisting in coordinating the direct labor and test technician operations
Follow and support required cGMP production processes and procedures.
Monitor production metrics and support corrective actions as needed.
Ensure strict adherence to FDA regulations and GMP guidelines through audits and daily oversight.
Help coordinate and develop training documentation and plans for assembly team members.
Collaborate with the Quality Assurance and Quality Control teams to address quality issues.
Help identify opportunities for process optimization and efficiency improvements.
Implement lean manufacturing principles to streamline operations.
Participate in and support continuous improvement projects.
Supervise and support a team of assembly personnel, and participate in the interviewing/hiring process as needed
Foster a culture of teamwork, accountability, and continuous improvement.
Participate in performance evaluations and provide coaching to team members.
Promote a safe working environment by enforcing safety protocols.
Investigate and report safety incidents, implementing preventive measures.
Monitor department costs and escalate concerns as appropriate
Education, Qualifications, and/or Experience:
Associate’s degree required with bachelor’s degree preferred
At least 5 years of experience in manufacturing operations or equivalent role(s) required, preferably in the medical device industry
Experience operating in environments of FDA regulations and GMP guidelines required
Excellent problem-solving and decision-making skills.
Ability to support process improvements and contribute to cost reduction efforts.
Ability to work collaboratively, explain the ‘Why,’ and be able to influence others in a fast-paced environment.
Ability to operate with general supervision and escalate issues appropriately.
Ability to work cross-functionally to ensure all manufacturing objectives are met.
Possesses a high level of attention to detail and organization.
Ability to prioritize tasks and to delegate them when appropriate.
Experience in using/navigating ERP systems
Proficient with Microsoft Office Suite or related software to complete reports and logs.
Physical Requirements:
Repetitive Motion: Mostly computer use
Weight Lifting: at least 25 lbs
Position: Mostly sitting
Speaking and communicating
Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas
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