Production Lead- A & B-shift (12hr rotating shift) Drug Delivery

SMC Ltd.•Devens, MA

50d

About The Position

Step into a leadership role where your expertise truly makes an impact. At SMC Ltd., we’re growing fast and looking for hands-on leaders who thrive in a dynamic, high-performing manufacturing environment. As a key driver on the assembly floor, you’ll play an essential role in guiding your team, maintaining quality and compliance, and helping deliver life-changing medical products to patients around the world.

Requirements

Demonstrated abilities in prioritization, multi-tasking, problem solving while maintaining strong attention to detail and willingness to collaborate in a team environment.
Excellent customer service skills, communication skills, comprehensive and troubleshooting skills are necessary.
Able to skillfully navigate obstacles to generate positive outcomes.
Strong interpersonal and communication skills; be a team player; and have the ability to develop a team atmosphere. Must be able to communicate with all levels of staff.
Ability to understand and practice company and customer quality requirements.
Knowledge and practical understanding of various assembly methods and secondary operations equipment. Knowledge of equipment setup, operating techniques, and troubleshooting.
The ability to visualize and help design/develop tools, fixtures, processes to obtain maximum efficiency.
Working knowledge of ISO, FDA, GMP, and OSHA standards.
Technical background desirable.
Competent in the use of computers, basic Microsoft Office Suite, bar code readers, with the ability to access and enter data as necessary.
Ability to read, write and communicate in English.
High School Diploma or equivalent required.

Responsibilities

Support sustaining (Set-In-Order) standards for general work areas of the assembly operation.
Provide and maintain skill set necessary to properly operate, inspect and package product on the assembly room floor.
Drive expectations (Set-In-Order) “clean and tidy” standards, for all work areas.
Set up Assembly, Packaging, and Test equipment, per validated processes, to produce medical devices or sub-assemblies.
Work with Quality Technicians for start-up approval of production lines.
Monitor and provide ongoing feedback regarding the daily performance of shift employees and help to ensure product conformance to customer specifications and scheduled delivery dates, while helping to monitor the quality, production, scrap, safety, cost and customer service for the shift.
Perform initial and refresher training for temporary and full-time employees to proper work methods per specifications and standard work instructions (SWI’s).
Adhere to clean room processes and procedures.
Regular attendance and professionalism.
Set up, troubleshoot and assist in resolving process/equipment problems. Monitor processes, policies and procedures and recommend improvements in production methods, equipment, operating procedures, working conditions (safety, quality, productivity, and cost) and cost effectiveness.
Work closely with customer service, quality, scheduling and various other departments to ensure production and quality of products meets specifications and delivery times.
Post daily production, daily scrap, and monitor inventory of product used.
Maintain lot traceability and perform line clearance and reconciliation, as required.
Investigate and resolve production material variances.
Perform Corrective and Preventative Action duties (CAPA), Continuous Improvement and 6S Lean activities as assigned.
Where errors exist, revise/write standard work instructions for review, approval and submission to document control.
Other duties as assigned.