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Quality Assurance Specialist bei undefined

undefined · Westminster, Vereinigte Staaten Von Amerika · Onsite

81.156,00 $  -  106.517,00 $

Jetzt bewerben

 

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)

 

  • Must possess strong communication skills for Interactions with internal and external customers.
  • Work independently with some supervision and have initiative to drive projects forward.
  • Ability to work on a variety of projects and shift priorities as needed.
  • Ability to prioritize, organize, and plan to achieve due dates, and communicate any obstacles in a timely manner.
  • Computer skills required – Windows, MS Office (with an emphasis on Excel and Word).

 

Education/Experience Requirements

 

  • Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Microbiology, or related field.
  • 3+ years of experience or equivalent combination of education and experience in medical device, biotechnology, or pharmaceutical field.

 

Travel Requirements

 

 The role will require occasional travel up to 20% 

 

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