Manufacturing Supervisor

Nuclein, LLC; Austin (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

Nuclein, LLC is seeking a Manufacturing Supervisor to oversee daily production, ensure compliance with FDA regulations and GMP guidelines, and drive continuous improvement for quality and efficiency. The role involves leading the assembly team, coordinating training, and collaborating with QA/QC to resolve issues in a fast-paced environment.

The ideal candidate has 5+ years in manufacturing operations, an associate degree (bachelor’s preferred), and experience with ERP systems and MS Office.

Qualifications

• Associate degree required; bachelor’s degree preferred.
• 5+ years in manufacturing operations, preferably in medical device.
• Experience with FDA regulations and GMP guidelines.
• Strong problem-solving and decision-making skills.
• Experience operating ERP systems.

Responsibilities

• Oversee day-to-day manufacturing activities and resources.
• Ensure cGMP processes and procedures are followed.
• Monitor production metrics and drive corrective actions.
• Ensure FDA and GMP compliance through audits.
• Coordinate training documentation for assembly staff.
• Collaborate with QA/QC to address quality issues.
• Lead continuous improvement and lean manufacturing efforts.
• Supervise assembly personnel and participate in hiring.
• Promote safety and conduct incident investigations.
• Monitor department costs and escalate concerns.

Skills

Leadership

Problem solving

Communication

Cross-functional teamwork

Education

Associate's degree

Bachelor's degree preferred

Tools

ERP systems

Microsoft Office

Job 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 elevate 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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