Production Manager (Regulated Medical Device Manufacturing)
We are looking for a skilled and dedicated
Production Manager
to lead our manufacturing operations and ensure the efficient, high-quality production of medical devices. This pivotal role demands expertise in regulatory compliance, process improvement, and strong team leadership.
Key Responsibilities
* Operational Oversight:
Direct daily production activities to meet critical targets for
safety, quality, delivery, and cost
.
* Team Leadership:
Manage, train, and develop
production teams, including supervisors, leads, and operators, fostering a high-performance work environment.
* Materials and Logistics:
Manage production planning and scheduling
to align output with customer demand,
including oversight of materials management and warehouse operations.
* Compliance and Quality:
Ensure all manufacturing processes strictly comply with
FDA, ISO 13485
, and other relevant regulations.
* Planning & Control:
Oversee production scheduling and resource allocation, managing inventory and output to align with customer demand.
* Continuous Improvement:
Monitor key performance indicators (KPIs) and lead initiatives to optimize processes using
Lean and Six Sigma
methodologies.
* Cross-Functional Collaboration:
Partner with Engineering, Quality Assurance, and Supply Chain to resolve production issues and support the transfer of new products into manufacturing.
* Documentation & Audits:
Maintain accurate production documentation and lead manufacturing-related audits and inspections.
Required Qualifications
* Experience:
A minimum of
5 years
of experience in a production management role within the
medical device or a similarly regulated manufacturing
environment.
* Education:
Bachelor's degree in Engineering, Manufacturing, or a related technical field.
* Technical Expertise:
Strong working knowledge of
GMP, ISO 13485, and FDA
regulations.
* Skills:
Proven leadership ability, team development experience, and practical application of
Lean Manufacturing and Six Sigma
principles.
* Communication:
Excellent problem-solving, organizational, and professional communication skills.