Sterilization/Cleanroom Quality Assurance Specialist

6 days ago


Bellingham, Massachusetts, United States KARL STORZ Endoscopy - America Full time
Senior Quality Engineer Role at KARL STORZ Endoscopy - America

We are seeking a seasoned Senior Quality Engineer to support our quality assurance efforts, focusing on sterile and non-sterile product lines. This position will ensure compliance with quality and sterilization standards, prioritizing patient safety and regulatory requirements.

Responsibilities:
  • Spearhead quality initiatives and process improvements, leveraging expertise in sterilization processes and cleanroom environments.
  • Collaborate with cross-functional teams (engineering, production, regulatory) to drive high-impact projects and continuous improvement.
  • Analyze quality data, prepare inspection procedures, and review engineering changes to maintain product excellence.
  • Supervise and mentor technicians, providing training to QA and manufacturing teams to foster a culture of quality.
  • Ensure environmental monitoring and product sterility requirements are met, adhering to FDA, ISO, and MDR regulations.
Requirements:
  • Bachelor's degree in engineering, accompanied by 5+ years of experience in medical device manufacturing and quality assurance.
  • Proven knowledge of sterilization, clean rooms, machining, and injection molding, as well as proficiency in statistics, SPC, and quality engineering tools.
  • Strong communication, problem-solving, and organizational skills, with the ability to work effectively in a team environment.
  • Experience with MS Office, SAP, and quality tools like Six Sigma and Minitab is preferred.

Estimated salary: $120,000 - $150,000 per annum.



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