Quality Assurance Specialist at HighRidge Medical LLC

Westminster, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Jan, 26

Salary

106517.0

Posted On

03 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Manufacturing Cleaning, Sterilization, FDA Regulations, EU MDD, ISO Standards, Residue Analysis, Bioburden Testing, Endotoxin Assessments, Root Cause Analysis, Technical Training, SOP Authoring, Data Entry, Communication Skills, Project Management, Computer Skills

Industry

Medical Equipment Manufacturing

Description

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%

Responsibilities

Lead the manufacturing cleaning and terminal sterilization programs for Highridge Medical product lines. Collaborate with R&D and Operations teams to ensure compliance with regulatory and product safety requirements.