Regenity Biosciences
Quality Control Lead
Regenity Biosciences.
Base pay range:
$27.00/hr - $32.00/hr
Position Summary
The Quality Control Lead is responsible for verifying that receiving, in-process, and finished products meet documented specifications. This role oversees key QC programs, assigns and schedules daily activities, and participates in cross-functional project teams. The ideal candidate demonstrates professionalism, maturity, confidentiality, and serves as a direct backup to the QC Supervisor or Manager.
Key Responsibilities
Coordinate, oversee, and conduct verification activities for receiving, inprocess, and finished products in accordance with SOPs.
Inspect and test materials and products following established procedures.
Identify, document, and elevate issues related to product quality, processes, or the quality system.
Write and revise Standard Operating Procedures (SOPs) and product specifications.
Oversee one or more QC programs (e.g., Validations, Equipment Control, Shelf Life).
Partner with Manufacturing Supervisors to coordinate inspection and testing requirements.
Develop and write test protocols for shelf–life studies, validations, and other projects.
Maintain accuracy and compliance of quality records per documented procedures.
Write Process Deviations and Engineering Change Orders (ECOs) and track approval status.
Design and execute testing strategies for investigations.
Serve as liaison to R&D, QA, Materials Management, and Regulatory to support audits, product release, documentation, and transfer activities.
Schedule QC personnel to meet workflow and operational demands.
Release or quarantine inprocess materials based on inspection/testing outcomes.
Initiate investigations and recommend corrective actions as needed.
Recommend Material Review Board meetings when appropriate.
Qualify personnel to perform specific QC tasks.
Participate in internal and external audits.
Participate on project teams and support department initiatives.
Review and approve QC records as required.
Assist with additional ad hoc projects, documentation coordination, and training activities.
Education & Experience
Bachelor’s degree in the biological sciences or equivalent medical device QC experience.
Familiarity with inspection and test methods used in product development and quality control.
Experience within the medical device or scientific field is preferred.
Strong written and verbal communication skills.
Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Ability to follow written and verbal instructions with minimal supervision.
Strong organizational skills and the ability to manage multiple priorities in a team environment.
Physical Demands
This role may require standing, walking, sitting, climbing stairs, and using hands to handle tools or equipment. The employee may occasionally lift or move items up to 50 lbs. Regular travel between Regenity’s sites may be required.
Supervisory Responsibilities
This position includes direct oversight of QC personnel performing various quality control functions and serves as a backup to the QC Supervisor or Manager.
Other Duties As Required
Please note: This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time with or without notice.
Regenity offers a comprehensive rewards package:
Company performance bonus eligible
401(k) plan with company contribution
Paid time off and holidays
Medical, Rx, dental and vision insurance
Company paid life and AD&D insurance
Wellness and Employee Assistance Program (EAP)
Tuition Reimbursement
Salary Range: $27-$32
Seniority level : Mid-Senior level
Employment type : Full-time
Job function : Quality Assurance
Industries : Medical Equipment Manufacturing
#J-18808-Ljbffr
Base pay range:
$27.00/hr - $32.00/hr
Position Summary
The Quality Control Lead is responsible for verifying that receiving, in-process, and finished products meet documented specifications. This role oversees key QC programs, assigns and schedules daily activities, and participates in cross-functional project teams. The ideal candidate demonstrates professionalism, maturity, confidentiality, and serves as a direct backup to the QC Supervisor or Manager.
Key Responsibilities
Coordinate, oversee, and conduct verification activities for receiving, inprocess, and finished products in accordance with SOPs.
Inspect and test materials and products following established procedures.
Identify, document, and elevate issues related to product quality, processes, or the quality system.
Write and revise Standard Operating Procedures (SOPs) and product specifications.
Oversee one or more QC programs (e.g., Validations, Equipment Control, Shelf Life).
Partner with Manufacturing Supervisors to coordinate inspection and testing requirements.
Develop and write test protocols for shelf–life studies, validations, and other projects.
Maintain accuracy and compliance of quality records per documented procedures.
Write Process Deviations and Engineering Change Orders (ECOs) and track approval status.
Design and execute testing strategies for investigations.
Serve as liaison to R&D, QA, Materials Management, and Regulatory to support audits, product release, documentation, and transfer activities.
Schedule QC personnel to meet workflow and operational demands.
Release or quarantine inprocess materials based on inspection/testing outcomes.
Initiate investigations and recommend corrective actions as needed.
Recommend Material Review Board meetings when appropriate.
Qualify personnel to perform specific QC tasks.
Participate in internal and external audits.
Participate on project teams and support department initiatives.
Review and approve QC records as required.
Assist with additional ad hoc projects, documentation coordination, and training activities.
Education & Experience
Bachelor’s degree in the biological sciences or equivalent medical device QC experience.
Familiarity with inspection and test methods used in product development and quality control.
Experience within the medical device or scientific field is preferred.
Strong written and verbal communication skills.
Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Ability to follow written and verbal instructions with minimal supervision.
Strong organizational skills and the ability to manage multiple priorities in a team environment.
Physical Demands
This role may require standing, walking, sitting, climbing stairs, and using hands to handle tools or equipment. The employee may occasionally lift or move items up to 50 lbs. Regular travel between Regenity’s sites may be required.
Supervisory Responsibilities
This position includes direct oversight of QC personnel performing various quality control functions and serves as a backup to the QC Supervisor or Manager.
Other Duties As Required
Please note: This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time with or without notice.
Regenity offers a comprehensive rewards package:
Company performance bonus eligible
401(k) plan with company contribution
Paid time off and holidays
Medical, Rx, dental and vision insurance
Company paid life and AD&D insurance
Wellness and Employee Assistance Program (EAP)
Tuition Reimbursement
Salary Range: $27-$32
Seniority level : Mid-Senior level
Employment type : Full-time
Job function : Quality Assurance
Industries : Medical Equipment Manufacturing
#J-18808-Ljbffr