Quality Engineering Coordinator - Scottsdale, United States - Surgenex LLC

Surgenex LLC

Verified Company

Scottsdale, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

About Us:
SURGENEX is a privately held biotechnology company and accredited Tissue Bank by the AATB. Our company is headquartered in Scottsdale, Arizona. We develop, manufacture, and distribute the highest quality tissue allograft in the industry to accounts within the United States.

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 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 ahead of changes in regulations and standards, pertaining to the biomedical and tissue banking industry ad 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.
Assisting 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: validations and production documentation, equipment logs, cleaning logs.
Maintaining accurate and comprehensive documentation of quality activities, including validations 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 in quality management and statistical analysis is desirable