Quality Assurance Manager

Quality Assurance Manager Shu-Tung and Alice Li Foundation Oakland, NJ Job Details Full-time $90,000 - $125,000 a year 4 hours ago Benefits Relocation assistance Health insurance Dental insurance Paid time off Vision insurance 401(k) matching Qualifications Record keeping Document review (document control) GLP ISO standards Regulatory compliance GMP Bachelor's degree Team management Attention to detail Quality standards in production Training & development Research & development Editing FDA regulations Time management

Full Job Description Description:

Quality Assurance Manager Reporting to:

President Location:

Bergen County, NJ Position Type:

Full Time - Temp to

Perm Position Summary:

Invention-Translation-Regeneration The Shu-Tung and Alice Li Foundation is seeking a highly motivated and detail-oriented Quality Assurance Manager to join our Laboratory for Tissue Engineering Research. Our mission is to develop and advance innovative tissue-equivalent products for regenerative treatment of complex and difficult-to-heal tissues and organs. This role offers a unique opportunity to contribute to cutting-edge translational research in a non-profit setting. The successful candidate will play a key role in maintaining regulatory compliance, driving quality assurance initiatives, and supporting ongoing product development through robust quality systems.

Key Responsibilities:

Develop, implement, and maintain comprehensive Quality Assurance processes, including SOPs, controlled documentation, protocols, CAPA records, and best practices Ensure the Quality Management System (QMS) complies with

FDA 21 CFR

Part 820, ISO 13485, and other relevant regulatory standards Plan and conduct internal and external audits and quality assessments; identify deviations and recommend corrective actions Oversee and improve Document Control systems, including SOP creation, revision, and change management workflows Collaborate closely with the Research & Development team to align quality practices with product development goals Develop and execute validation protocols for equipment and processes; maintain associated documentation Analyze quality metrics and trends to identify systemic issues and recommend data-driven improvements Lead investigations and documentation for CAPA, non-conformance reports (NCRs) , deviations, and risk management processes Provide training and support to staff to ensure organization-wide adherence to quality standards and procedures Support continuous improvement initiatives to enhance the overall effectiveness of the

QMS Qualifications:

Bachelor's Degree in Life Sciences or a related scientific discipline Minimum 5-10 years of experience in Quality Assurance roles within the medical device or biotechnology industry Demonstrated expertise in Quality System documentation, document control, and regulatory compliance Strong knowledge of

FDA 21 CFR

Part 820, ISO 13485, GMP, and GLP standards Strong leadership skills with a proven record in leading a team Excellent written and verbal communication skills; ability to draft, edit, and review documentation with precision Proficient in analyzing data and implementing quality improvements based on findings Detail-oriented and highly organized, with strong time management and prioritization skills Experience working with or supporting Research and Development teams is preferred About the Shu-Tung and Alice Li Foundation The Shu-Tung and Alice Li Foundation is a non-profit 501(c)(3) organization committed to developing novel approaches for the repair of difficult-to-heal tissues and ultimately translating them to clinical practice to advance regenerative medicine for the treatment of injured and damaged tissues and organs. Research grants are offered to both emerging researchers with demonstrated independent research potential and established investigators working in areas aligned with our mission. We strive to build a creative environment which promotes innovation while maintaining a solid allegiance to Basic Science. Compensation and Benefits The Shu-Tung and Alice Li Foundation offers a competitive commensurate with experience and qualifications, along with a comprehensive benefits package that includes medical, dental, and vision insurance, and retirement plan options. Equal Employment Opportunity Statement The Shu-Tung and Alice Li Foundation is committed to providing equal employment opportunities to all employees and applicants. We do not discriminate on the basis of race, religion, color, age, sex, national origin, sexual orientation, gender identity, genetic information, neurodiversity, disability, veteran status, or any other status protected by applicable law.

Job Type:

Full-time Pay:

$90,000.00 - $125,000.00 per year

Benefits:

401(k) matching Dental insurance Health insurance Paid time off Relocation assistance Vision insurance

Work Location:

In person