NextPhase Medical Devices LLC is a fast growing, contract manufacturer of single- use disposable medical devices. Headquartered in Waldwick, NJ, we also have manufacturing facilities in Rochester, NH and Tijuana, Mexico.
The Production Assistant provides leadership, direction and clear communication of the daily expectations to Assemblers. Production Assistants interact regularly with various support groups such as Engineering, Purchasing, Quality, Customer Service, Materials and Human Resources. The primary objective of the Production Assistant is to assist Team Leads and Production Supervision with proper allocation of direct resources to achieve the planned production goals, ensuring Safety, Quality, Delivery and Cost objectives are also achieved. Production at NextPhase occurs in Class 7 & 8 Clean Rooms and requires proper gowning including hair/beard and shoe coverings, gloves and gowns be worn at all times while in the Clean Rooms.
- Ensure proper training of Assemblers and adherence to Standard Operating Procedures (SOP’s) and Assembly Procedure (AP’s) in all operations and activities.
- Schedule production in a manner that meets customer commitments while effectively utilizing resources.
- Facilitate training and development of Assemblers to support changing customer demands and promotional opportunities for team members.
- Keep and maintain all required documentation per SOP’s.
- Assist Team Leads and Production Supervision with hiring and performance management.
- Ensure proper Line Setup, Line Clearing, and Product Traceability occurs.
- Support the proper maintenance of machinery and equipment in conjunction with Facilities and Engineering.
- Maintain Kanban’s where they exist.
- Recommend, implement and support continuous improvement initiatives and tools.
- Work with Engineering to investigate and resolve process issues and implementation of new products on the manufacturing area.
- Update information in the Company’s ERP system, IQMS, including part and work order information as well as management of employees’ clocking in/out and tasking in/out.
Skills & Experience Required:
- 3+ years of related experience in a Manufacturing environment, ideally in a regulated industry, preferably with ISO-13485 knowledge
- Experience working in an ERP system, preferably IQMS
- Strong communication skills
- Ability to read, comprehend and execute SOP’s, AP’s and Work Instructions
- Basic computer experience including Microsoft Office
- Basic Math capability
- Must be able to stand for extended periods, typically the full duration of an 8-hour shift
First Shift Hours:
- Monday – Friday 3:30pm – 1:00am
- Overtime may be required before, after and on weekends