MedTech Production Lead — Quality, GMP & Team Leadership

Regenity Biosciences; Oakland (NJ); On-site; USD 39,000 - 44,000; Full time

Benefits offered by this job

Performance bonus

401(k) plan

Paid time off

Medical insurance

Tuition Reimbursement

Job summary

Regenity Biosciences in Oakland, NJ, is seeking a Product Line Leader to supervise production of quality medical devices and coordinate manufacturing efforts. You will ensure adherence to batch records, SOPs, cGMPs and safety requirements while supporting process improvements and cost containment.

The role requires strong leadership, ability to transfer processes from R&D to commercial launch, develop validation plans, train staff, and maintain documentation.

Qualifications

• Minimum GED/high school diploma with 4 years in medical device/pharma manufacturing.
• Bachelor degree in engineering or sciences with 2 years related experience.
• Proficient with Microsoft Word, Excel, PowerPoint.

Responsibilities

• Supervise manufacturing team for production of assigned products.
• Oversee transfer of processes from R&D to commercial launch.
• Develop and implement validation protocols and master plans.
• Write and revise Batch Records and SOPs.
• Ensure quality records and GMP documentation.

Skills

Manufacturing leadership

Process improvement

Quality systems

Documentation

Team training

Education

GED/high school diploma

Bachelor’s degree in engineering or sciences

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Regenity Biosciences in Oakland, NJ, is seeking a Product Line Leader to supervise production of quality medical devices and coordinate manufacturing efforts. You will ensure adherence to batch records, SOPs, cGMPs and safety requirements while supporting process improvements and cost containment.

The role requires strong leadership, ability to transfer processes from R&D to commercial launch, develop validation plans, train staff, and maintain documentation.