Manufacturing Lead

Argen Corporation • San Diego, CA

1d

About The Position

A Manufacturing Lead produces standard and/or custom medical devices to meet customer requirements by following standard work instructions and company policies while manufacturing Argen products in a team environment.

In this role, the successful candidate:

Follow department SOPs and work instructions and adhere to customer and Argen standards for manufacturing products.
Adhere to work instructions to properly operate and maintain equipment as needed.
Visually inspect product quality, troubleshoot and escalate issues when necessary.
Report & escalate equipment per work instructions.
Ensure team meets daily Service Level Agreement (SLA) expectations.
Identify and recommend disposition of defective items for rework or scrap.
Understand the product manufacturing process from initial steps through final inspection.

Make line balancing personnel adjustments as required to maintain production flow and communicate all adjustments to the Supervisor.
Clearly communicate instructions and operational expectations to team members.
Periodically inspect product to ensure quality levels are maintained.
Complete all documentation and training as required.

Assist in authoring and/or revising SOPs and work instructions as needed.
Support R&D Engineering products as requested by supervisor.
Maintain a safe and clean work area, wear appropriate PPE, and adhere to safety standards.
Ensure
safety guidelines are followed by all team members.
Train all manufacturing associates on all SOPs and work instructions in area.
Serve as a subject matter expert in area.
Other duties as assigned.

Requirements

• High school diploma or equivalent required.
• Five plus years of experience working in a manufacturing environment preferred.
• Strong knowledge of all manufacturing procedures with the ability to train others.
• Possesses leadership qualities and leads a manufacturing team in achieving results in a high-volume manufacturing environment.
• Possesses leadership qualities such as self-awareness, team focus, ability to translate learning into action, and train others to do so, as well as drive success.
• Ability to work in a team environment.
• Ability to follow instructions and readily accept additional responsibilities.
• Attention to detail and quality focused.
• Passionate about industry and desire to contribute where needed.
• Schedule adherence and dependability.
• Ability to meet tight deadlines and meet production goals.
• Ability to learn technical concepts by reading work instructions and standard operating procedures, and completing on-the-job training.
• Ability to effectively communicate in both written and verbal form.
• Ability to follow detailed directions in a Good Manufacturing Practices (GMP) environment required.

Nice To Haves

• Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred.

Responsibilities

• Follow department SOPs and work instructions and adhere to customer and Argen standards for manufacturing products.
• Adhere to work instructions to properly operate and maintain equipment as needed.
• Visually inspect product quality, troubleshoot and escalate issues when necessary.
• Report & escalate equipment per work instructions.
• Ensure team meets daily Service Level Agreement (SLA) expectations.
• Identify and recommend disposition of defective items for rework or scrap.
• Understand the product manufacturing process from initial steps through final inspection.
• Make line balancing personnel adjustments as required to maintain production flow and communicate all adjustments to the Supervisor.
• Clearly communicate instructions and operational expectations to team members.
• Periodically inspect product to ensure quality levels are maintained.
• Complete all documentation and training as required.
• Assist in authoring and/or revising SOPs and work instructions as needed.
• Support R&D Engineering products as requested by supervisor.
• Maintain a safe and clean work area, wear appropriate PPE, and adhere to safety standards.
• Ensure safety guidelines are followed by all team members.
• Train all manufacturing associates on all SOPs and work instructions in area.
• Serve as a subject matter expert in area.
• Other duties as assigned.

Benefits

• Health/Dental/Vision Plans
• 401k with Employer Match
• Paid Vacation, Holiday and Sick Time
• Employee Events
• Wellness Programs
• Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED