Quality Assurance Specialist

6 days ago

Minneapolis, Minnesota, United States Saluda Medical Full time
Job Title: Quality Inspector

At Saluda Medical, we are committed to delivering high-quality medical devices that meet the needs of our customers. We are seeking a highly skilled Quality Inspector to join our team.

Job Summary:

The Quality Inspector will be responsible for performing quality control inspections and reviews to ensure that our products meet the required standards. This includes reviewing manufacturing processes, testing results, and identifying nonconformances. The successful candidate will have a strong attention to detail, effective communication skills, and the ability to work independently.

Key Responsibilities:
  • Perform quality control inspections in accordance with established procedures.
  • Review manufacturing processes, including product sterilization load parameters, test results, and identify nonconformances.
  • Complete required documentation in accordance with Good Documentation Practices to record results of inspections.
  • Collaborate with Engineers and Supply Chain to initiate, contain, investigate, and manage nonconformances.
  • Manage product microbial testing, including sampling, in accordance with established procedures.
  • Comply with applicable regulatory requirements, including FDA, EU, and TGA Regulations, and Saluda Medical's Quality Management System.
  • Participate and support internal and external audits of Saluda Medical site processes and compliance with established procedures.
Requirements:
  • 5 years of experience in the medical device industry or other regulated industry.
  • Demonstrated strong attention to detail.
  • Effective verbal and written communication skills in working with varying levels and functions of an organization.
  • Ability to work on-site at Saluda Medical Minnesota site (Bloomington) 5 days a week.
Desirable Requirements:
  • An understanding of the requirements of ISO 13485 and 21CFR 820.
  • LEAN manufacturing training.
  • Experience in Product Microbial Testing.

Saluda Medical is an equal opportunities employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity and promotes equal opportunities for all employees.

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