Quality Assurance Specialist at undefined
undefined · Westminster, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Office in Westminster
Job Description
Job Title: | Quality Assurance Specialist | Grade: | Z11 |
Job Function: | Quality | FSLA: | Exempt |
Position ID: | 710637990 | Posting Range: | $81,156-106,517 |
Job Summary
Seeking a highly skilled Quality Assurance Specialist with a strong scientific background to lead the manufacturing cleaning and terminal sterilization programs for the Highridge Medical product lines. Under direction of the department manager, the team member will work closely with the R&D and Operations teams to ensure the manufacturing cleaning of implants and instruments and sterilization terminally sterilized product meet all regulatory and product safety requirements. |
Principal Duties and Responsibilities
Material Documentation Support and Testing
- Experience with manufacturing cleaning and sterilization per FDA, EU MDD, and EU MDR and ISO requirements (i.e. ISO19227, ISO11137, ISO11737, ST79, ST98)
- Applies chemistry principles to evaluate cleaning agents, residue removal, and material compatibility
- Conduct residue analysis, bioburden testing, and endotoxin assessments in collaboration with microbiology and analytical labs
- Troubleshoot and optimize cleaning and sterilization processes using root cause analysis and risk-based approaches
- Support the sterilization requalification and radiation dose audit programs to ensure continuity of validated processes
- Coordinate validations and process monitoring for manufacturing cleaning program across company vendors and gamma sterilization of terminally sterilized products. This can include (but not limited to): bioburden testing, sterility testing, inorganic and organic residuals, cytotoxicity, and endotoxin testing)
- Work closely with R&D, Manufacturing, Quality Assurance, and Regulatory Affairs to support new product development and lifecycle management.
- Provide technical training and guidance to production and quality teams on cleaning and sterilization procedures
- Authors and revises SOPs using the electronic quality management system
- Authors and revises risk-based rationales
Data Searching
- Maintenance and data entry in Contact Material Database.
- Research contact material safety and Ingredients for developing contact material families.
Expected Areas of Competence (i.e., knowledge, skills and abilities)
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Education/Experience Requirements
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Travel Requirements
The role will require occasional travel up to 20% |
