Quality Engineering Coordinator

2 months ago

Scottsdale, United States Surgenex Full time

Details

**Posted**: 15-Apr-24

**Location**: Scottsdale, Arizona

**Type**: Full Time

**Salary**: $50,000-$70,000

**Categories**:

- Biomedical - Biotechnology
- Biomedical Engineering

**Salary Details**:

- Salary is based on past experience

**Preferred Education**:

- 4 Year Degree

**Additional Information**:

- Employer will assist with relocation costs.

**Internal Number**: 1121

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

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