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Quality Assurance Specialist

1 month ago

Lebanon, New Hampshire, United States Gauthier Biomedical Inc. Full time
Job Overview

Gauthier Biomedical Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the verification, validation, and testing of our products meet customer expectations, industry standards, and regulatory requirements.

Key Responsibilities:

  • Develop and initiate quality plans from engineering drawings, meeting company requirements for FDA and ISO design control as well as customer requirements.
  • Determine gage and fixture requirements.
  • Perform risk mitigations activities, including PFMEA, Control Plans, Validations, Internal Audits, and GR&R.
  • Analyze quality data, identify problem areas, and assist in resolving manufacturing processes or methods that affect quality.
  • Perform Design of Experiments.
  • Assist with the inspection of components and final assemblies.
  • Initiate and perform mechanical testing.
  • Perform process capability studies, recommending changes to improve quality.
  • Participate on cross-functional teams to address and resolve quality problems.
  • Act as a liaison to resolve customer issues, both internal and external.
  • Apply continuous improvement methods to enhance manufacturing processes, quality, reliability, and/or cost-effectiveness.
  • Perform internal and supplier audits.
  • Perform other assignments as necessary.
  • Maintain a professional working relationship and effectively communicate with all employees, managers, vendors, customers, and regulatory agencies.
  • Understand and comply with company policies and procedures, regulatory requirements, and safety regulations.
  • Regular attendance at work is required.

Requirements:

  • Bachelor's Degree in Mechanical or Biomedical Engineering or related field; two years of Quality Engineering experience; or equivalent combination of education and experience.
  • Knowledge of manufacturing processes and testing methods.

Gauthier Biomedical Inc. offers a solid compensation and benefits package, including health, dental, vision, life, and short-term disability insurance, a 401K plan with company match, Flexible Spending Accounts, and more. We provide a Personal Time Off (PTO) program that combines vacation time, sick time, and personal days off into one benefit, which starts accruing on the employee's first paycheck. We have state-of-the-art equipment and technology in our air-conditioned building in Grafton, WI. We also have an on-site 24-hour Fitness Center, a Ping-Pong table, and an outdoor Basketball court. We have a courtyard in the center of the building for cookouts and outdoor lunch breaks, and we host several company events throughout the year. We are serious about fun.

Visit our website, www.gauthierbiomedical.com, to learn about our company and open positions. If you are willing to learn, have a great work ethic, and are qualified for one of our posted positions, we encourage you to apply. Complete our Employment Application on our website and email it with your resume to hr@gauthierbiomedical.com.

All employment decisions are made on the basis of qualifications, merit, and business need. Gauthier Biomedical Inc. values diversity and is an Equal Opportunity Employer. We are a Drug-Free Workplace, where medical devices and rewarding careers are built.

If you're looking for a great place to work, you just found it. See for yourself what makes Gauthier Biomedical Inc. a great place to work.