Strategic Production Control Lead — Medical Devices

Cogmedix; West Boylston (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Cogmedix in West Boylston, Massachusetts, is seeking a Senior Production Control Specialist to create and manage production work orders. Key responsibilities include ensuring compliance with regulatory standards and collaborating with various departments to support production goals. The ideal candidate will have strong organizational skills, ERP expertise, and a background in medical device manufacturing.

This role is pivotal for ensuring product traceability and efficient production processes, making it essential for successful regulatory audits.

Qualifications

• 3+ years of experience in a high mix low volume medical device manufacturing environment.
• Working knowledge of cGMP, FDA QSR, ISO 13485, safety guidelines.
• Ability to document solutions and communicate process updates.

Responsibilities

• Create, track and manage production work orders.
• Prepare and maintain accurate work order packets.
• Assist Production Supervisor with material requirements.
• Collaborate with Production Planners to meet deadlines.
• Maintain logs and tracking systems for issued DHRs.

Skills

Customer service attitude

Communication skills

Organization skills

ERP expertise (Epicor E10 preferred)

Understanding of BOM structures

Microsoft Office proficiency

Education

College degree preferred

3+ years of planning experience in medical device manufacturing

Job description

Cogmedix in West Boylston, Massachusetts, is seeking a Senior Production Control Specialist to create and manage production work orders. Key responsibilities include ensuring compliance with regulatory standards and collaborating with various departments to support production goals. The ideal candidate will have strong organizational skills, ERP expertise, and a background in medical device manufacturing.

This role is pivotal for ensuring product traceability and efficient production processes, making it essential for successful regulatory audits.