Company Overview Surgenex is a leading biotechnology organization dedicated to the development and commercialization of placental tissue and musculoskeletal-based implants that meet rigorous quality and safety standards. Our comprehensive processing capabilities enable us to supply traditional birth tissue and musculoskeletal allografts through innovative, customized implants, supported by a committed team focused on excellence in quality and customer service. Job Description The Quality Engineering Coordinator is a collaborative role that will assist in developing, maintaining, and improving the quality systems process. This position is very hands-on, with an emphasis on validating systems and processes to comply with federal, international, local and state laws and regulations and the American Association of Tissue Banking standards. Responsibilities (included but not limited to): Assessing and maintaining the validated state of all processes, computer, and analytical systems. Establish and execute quality assurance processes and procedures, including product inspections, testing protocols, and validation activities, to ensure product quality and reliability. Stay abreast of changes in regulations and standards pertaining to the biomedical and tissue banking industry and ensure the company's compliance with all applicable requirements. Conducting and completing validations, as necessary. Onboarding and performance of

IQ /OQ /PQ

of equipment as needed. Trending and tracking of data including but not limited to performance of equipment and validation results. Assist with conducting risk assessments and developing risk management plans to identify, evaluate, and mitigate risks associated with cadaveric and birth tissue products throughout their lifecycle. Assisting in ensuring that the entire tissue banking operation is in conformity with Surgenex

SOPM, AATB

Standards and applicable laws and regulations. Organization and completion of quarterly dose audits. Assist the Regulatory Department in conducting annual reviews/audits to ensure compliance. Conducting microbiological sampling of cleanroom surfaces and air as part of the Environmental Monitoring Program. Ensuring that Environmental Monitoring and Equipment Calibrations are performed at appropriate intervals. Responsible for Pull Force Testing/Packaging Integrity Surveillance, as needed. Reviewing and ensuring good documentation practices and accuracy of all documentation including but not limited to: validation and production documentation, equipment logs, cleaning logs. Maintain accurate and comprehensive documentation of quality activities, including validation reports, quality records, and regulatory submissions. Prepare and present quality metrics and reports to management as needed. Responsible for collaborating with processing, regulatory and other departments to ensure alignment on quality objectives, facilitate knowledge transfer, and support product development. Responsible for approval of incoming supplies/reagents. Assist and/or perform other duties as assigned.

Skills/Abilities Collaboration Problem Solving Technical Writing Validations Report Writing Temperature Monitoring Experience/Education:

B.S. in related field

• preferred Minimum 2 years of Quality Engineering Certified Quality Engineer (CQE) or similar is a plus Experience with software tools for quality management and statistical analysis is desirable This is a Full Time role that is M
• F 6am
• 3pm

Pay:

$62,000.00

• $65,000.

00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Retirement plan Vision insurance

Work Location:

In person