Senior Quality Assurance Inspector

2 weeks ago

Minneapolis, Minnesota, United States VitalPath Full time
Job Overview

Position: R&D Quality Inspector III

Company Overview

VitalPath is a reputable collaborator in the design and production of specialized medical devices, particularly catheters, that play a crucial role in enhancing patient health and functionality. Our commitment to this significant work fosters dynamic partnerships with our clients. As a growing organization, we pride ourselves on maintaining a close-knit, family-oriented atmosphere while offering competitive compensation and benefits. If you are passionate about making a positive impact in healthcare and thrive in a diverse and friendly workplace, we encourage you to consider this opportunity.

Position Summary

This role involves minimal supervision in conducting inspections of products and raw materials utilizing various inspection tools and methodologies. You will support and manage daily quality assurance processes, ensuring all documentation is thorough and precise. This position is integral to prototype development, design, clinical trials, and pre-production manufacturing.

Key Responsibilities

  • Conduct visual, dimensional, and functional inspections according to product specifications to ensure compliance with quality standards.
  • Perform incoming inspections on materials and purchased components, including consumables, subassemblies, and raw materials.
  • Carry out First Article Inspections.
  • Assist in or execute validation of testing methods.
  • Collaborate with engineering teams on new product initiatives.
  • Operate within a controlled environment.
  • Regularly utilize ERP and eQMS software, along with Microsoft Office applications.
  • Interpret and analyze various documents, including policies, procedures, drawings, and specifications.
  • Communicate effectively, both verbally and in writing, to fulfill essential duties.
  • Utilize standard quality inspection equipment such as microscopes, calipers, and other measurement tools.
  • Identify quality concerns and report them to management.
  • Detect and manage nonconforming materials, ensuring proper documentation and resolution.
  • Maintain compliance with good manufacturing practices (cGMP) and good documentation practices (GDP).
  • Ensure a clean and organized workspace.
  • Document all inspection activities accurately.
  • May involve training peers in quality inspection practices.
  • May provide suggestions for continuous improvement initiatives.

Qualifications

  • A minimum of 5 years of experience in quality inspection within the medical device sector, particularly in regulated environments.
  • Comprehensive understanding of quality control standards and testing methodologies.
  • Proficient in using inspection tools and techniques.
  • Familiarity with clean room operations.
  • Strong focus on customer satisfaction and results.
  • Demonstrated integrity and accountability.
  • Excellent teamwork and communication skills.
  • Detail-oriented with strong analytical abilities.
  • Proficient in Microsoft Office and capable of interpreting technical drawings.

Preferred Qualifications

  • Experience with eQMS and ERP systems.
  • Ability to work independently and collaboratively in a team setting.
  • Strong organizational skills and ability to prioritize tasks effectively.

Benefits

  • Comprehensive health and dental insurance options.
  • Vision insurance.
  • Health Savings Account with employer contributions.
  • Short and long-term disability coverage.
  • Paid time off and holidays.
  • 401K plan with company matching.
  • Competitive salary with opportunities for professional growth.

VitalPath is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work-related disabilities, veteran status, sexual orientation, gender identity, or genetic information.

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