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SMC Ltd · 2 months ago

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

Devens, MA, US

Full-time

Onsite

Mid Level

$26/hr - $30/hr

SMC Ltd. is a contract manufacturer specializing in the healthcare industry, focusing on high-quality medical products. The Production Lead will guide a team on the assembly floor, ensuring quality and compliance while delivering essential medical products to patients globally.

ManufacturingMedical Device

No H1B

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

Qualification

Process troubleshootingQuality complianceLean manufacturingISO standardsFDA regulationsGMP knowledgeCustomer service skillsTechnical backgroundMicrosoft Office SuiteEnglish proficiencyCommunication skillsTeam collaborationAttention to detail

Required

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

High School Diploma or equivalent required

Ability to read, write and communicate in English

Competent in the use of computers, basic Microsoft Office Suite, bar code readers, with the ability to access and enter data as necessary

Working knowledge of ISO, FDA, GMP, and OSHA standards

Technical background desirable

Bend, squat, climb, grasp, reach, lift or otherwise move frequently for extended periods

Lift, move or otherwise transfer up to 50 lbs. frequently, or more occasionally

Walk, stand or otherwise move about continuously

Exposure to machine shop physical hazards including chemicals which may require respiratory protection

Typically sits, grasps items and performs keyboarding for occasional operation of a computer

Preferred

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