5 years relevant experience in medical device industry
Experience with capa, complaint management, nonconformance reporting
Bachelor's degree in stem related field
The Senior QA Specialist is responsible for maintaining the Sterilization Facility's quality assurance program in accordance with Quality System requirements
Job Summary
The Senior QA Specialist is responsible for maintaining the Sterilization Facility's quality assurance program in accordance with Quality System requirements.
The role involves generating and executing protocols for sterilization processes including EO, Gamma, and X-Ray, along with equipment validation.
Arthrex offers comprehensive benefits including matching 401(k), paid parental leave, and free onsite medical clinics.
Matching Summary
The Senior QA Specialist is responsible for maintaining the Sterilization Facility's quality assurance program in accordance with Quality System requirements.
Skills & Requirements
Must-have
5 years relevant experience in medical device industry
Experience with CAPA, Complaint Management, Nonconformance Reporting
Bachelor's degree in STEM related field
Nice-to-have
Project management and risk management tools like FMEA
SAP or Pilgrim Quality Data software proficiency
Cross-functional team collaboration skills
Key Requirements
Bachelor's degree in STEM
5 years relevant experience
Medical Device industry experience
Knowledge of ISO 13485, ISO 11135, ISO 11137 standards