Medical Device Production Lead – Quality & Process Champion

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

Benefits offered by this job

Bonus (performance)

401(k) plan with company contribution

Paid time off and holidays

Medical, dental, vision insurance

Company-paid life and AD&D insurance

Wellness Program and EAP

Tuition Reimbursement

Job summary

The Product Line Leader at Regenity Biosciences will supervise the manufacturing team to produce quality medical device products in line with batch records and SOPs. You will drive process improvements, maintain compliance with cGMP and safety regulations, and oversee training and documentation to support ongoing operations.

You will also manage cost control, oversea technology transfers from R&D to production, and ensure timely validation plans while coordinating with cross-functional teams to

Qualifications

• This position requires a minimum of a GED/high school diploma with four (4) years of medical device or pharmaceutical manufacturing experience or a Bachelor’s degree in engineering or sciences with 2 years medical device or pharmaceutical manufacturing experience.
• Experience with Microsoft software applications (Word, Excel, Power Point)
• Ability to perform detailed document review
• Ability to work in a team environment.
• Strong organizational skills ability to simultaneously track multiple projects
• Excellent communication skills (oral and written)

Responsibilities

• Supervise manufacturing team responsible for production of assigned products.
• Assist in the manufacturing of products in accordance with Batch Records and SOPs.
• Ensure quality records, including logbooks, procedures, training records, etc. are completed.
• Implement process improvements with emphasis on quality, safety and cost reduction.
• Monitor and control production costs.
• Oversee the transfer of manufacturing processes from R&D to commercial launch.
• Develop and implement validation protocols and master plans.
• Enforce cGMP's, safety regulations and environmental requirements.
• Ensure assigned personnel are effectively trained in their job requirements.
• Investigate quality issues and prepare investigation reports (CARs).
• Write and revise Batch Records and SOPs.
• Prepare and track required GMP documents (ECOs, Process Deviations, Product Dispositions).
• Maintain adequate inventory to prevent backorders and excessive production costs.
• Prepare Annual Product reports and Quarterly trending.
• Initiate action to prevent the occurrence of nonconformities.
• Organize equipment files and meet preventive maintenance and calibration deadlines.
• Maintain supplies and requisition as needed.
• Perform performance management for all assigned personnel
• Interview and select new hires for assigned teams
• Assist with various special ad hoc projects and other duties as assigned

Skills

Manufacturing management

Leadership

Quality control

cGMP

Process improvement

Cost control

Documentation

Training

Interviewing

Project management

Education

GED/high school diploma

Bachelor's degree in engineering or sciences

Tools

Microsoft Word

Excel

PowerPoint

Job description

The Product Line Leader at Regenity Biosciences will supervise the manufacturing team to produce quality medical device products in line with batch records and SOPs. You will drive process improvements, maintain compliance with cGMP and safety regulations, and oversee training and documentation to support ongoing operations.

You will also manage cost control, oversea technology transfers from R&D to production, and ensure timely validation plans while coordinating with cross-functional teams to