Quality Engineer

2 months ago

Grafton, United States Gauthier Biomedical Inc. Full time
Job DescriptionJob Description

Summary: Ensures the verification, validation, manufacturing and testing of products meets customer expectations, industry standards, quality and regulatory requirements; performs investigations and testing to resolve quality issues.

 

Essential Duties and Responsibilities:

  • Develops and initiates quality plans from engineering drawings; meets company requirements for FDA and ISO design control as well as customer requirements.
  • Determines gage and fixture requirements.
  • Performs risk mitigations activities (PFMEA, Control Plans, Validations, Internal Audits and GR&R).
  • Analyzes quality data, identifies problem areas, and assists in resolving manufacturing processes or methods that affect quality.
  • Performs Design of Experiments.
  • Assists with the inspection of components and final assemblies.
  • Initiates and performs mechanical testing.
  • Performs process capability studies; recommends changes to improve quality.
  • Participates on cross functional teams to address and resolve quality problems.
  • Acts as a liaison to resolve customer issues, both internal and external.
  • Applies continuous improvement methods to enhance manufacturing processes, quality, reliability, and/or cost-effectiveness.
  • Performs internal and supplier audits.
  • Performs other assignments as necessary.
  • Maintains a professional working relationship and effectively communicates with all employees, managers, vendors, customers and regulatory agencies.
  • Understands and complies with company policies and procedures, regulatory requirements and safety regulations.
  • Regular attendance at work is required.

 

Qualifications:

  • 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.

 

Company DescriptionIf you are looking for a rewarding career and want to be part of an award winning team, you've come to the right place. Gauthier Biomedical is a proud manufacturer of high-quality instruments for the medical device industry. We are a one-stop shop that offers design engineering services and full production of orthopedic instruments from CNC machining, to metal fabrication, silicone molding and assembly. We put world class instruments into your surgeon’s hands

Our employees are the key to our success in a competitive marketplace. The collective skills, knowledge and work experiences of our employees enable us to be a World Class company. We seek talented individuals to develop and manufacture the innovative solutions that our customers expect, a dedication to excellence and a strong work ethic.

We offer our employees a solid compensation and benefits package including health, dental, vision, life & short term disability insurance, 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 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 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 a great place to work.

Notice to Staffing Agencies and Contract Recruiters: to protect the interests of all parties, Gauthier Biomedical will not accept unsolicited resumes or referrals from any source other than directly from a candidate. Please do not contact or forward resumes or referrals directly to any of our employees. Any unsolicited resumes will be considered Gauthier Biomedical property, and we are not responsible for any charges or fees related to unsolicited resumes or referrals.Company DescriptionIf you are looking for a rewarding career and want to be part of an award winning team, you've come to the right place. Gauthier Biomedical is a proud manufacturer of high-quality instruments for the medical device industry. We are a one-stop shop that offers design engineering services and full production of orthopedic instruments from CNC machining, to metal fabrication, silicone molding and assembly. We put world class instruments into your surgeon’s hands \r
\r
Our employees are the key to our success in a competitive marketplace. The collective skills, knowledge and work experiences of our employees enable us to be a World Class company. We seek talented individuals to develop and manufacture the innovative solutions that our customers expect, a dedication to excellence and a strong work ethic. \r
\r
We offer our employees a solid compensation and benefits package including health, dental, vision, life & short term disability insurance, 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.\r
\r
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 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. \r
\r
All employment decisions are made on the basis of qualifications, merit and business need. Gauthier Biomedical values diversity and is an Equal Opportunity Employer. We are a Drug Free Workplace, where medical devices and rewarding careers are built.\r
\r
If you're looking for a great place to work, you just found it. See for yourself what makes Gauthier Biomedical a great place to work.\r
\r
\r
Notice to Staffing Agencies and Contract Recruiters: to protect the interests of all parties, Gauthier Biomedical will not accept unsolicited resumes or referrals from any source other than directly from a candidate. Please do not contact or forward resumes or referrals directly to any of our employees. Any unsolicited resumes will be considered Gauthier Biomedical property, and we are not responsible for any charges or fees related to unsolicited resumes or referrals.

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