Job Description
Job Description
Job Title: Operations Line Lead
Department: Product Development/Operations
Reports To: Operations Supervisor/Operations Director
Date: June 2024
Qualifications
- 5+ years of experience in Medical Device manufacturing or equivalent combination of manufacturing experience
- Ability to work independently and motivate staff to meet required deadlines.
- Problem-solving and process improvement skills.
- Demonstrate excellence in leadership, coaching, and communication skills.
- Ability to facilitate change, foster innovation, and achieve results.
Essential Duties and Responsibilities (but are not limited to):
- Supports GMP manufacturing processes, handles operational tasks, and drives continuous improvement.
- Ensure work aligns with quality standards and regulations.
- Provide operational guidance for day-to-day manufacturing production.
- Make necessary judgment calls to align with schedule changes by prioritizing specific duties to stay on schedule.
- Train and oversee the training of new employees.
- Communicate with quality and facilities whenever there is an issue with the product or equipment.
- Complete Kitting Request.
- Generating Lot numbers from Lot Number Log and print associated Routers and MPs.
- Facilitate and Lead Tier 1 Meetings.
- Successful completion of all training in a timely fashion.
- Serve as a key part of the new hire selection and onboarding process.
- Assist in developing and revising Standard Operating Procedures (SOP), Work Instructions (WI), Device history records/Routers, or other quality documentation to support the production process.
- Perform hands-on value-added operations for device manufacturing and help and guide other team members.
- Positively represents and supports the company’s policies and procedures.
- Positively represent the company during tours by demonstrating techniques and sharing appropriate information.
Education/Experience:
- 5+ years’ experience in medical assembly
- Above-average manual dexterity
This job description is intended to describe the general nature and level of work being performed by employees assigned to this position. It is not intended to be an entire list of all activities, tasks and skills required of employees in this position.