Sr. Quality Engineer

QTS Medical Device Outsourcing; BLOOMINGTON (MN); On-site; USD 97,900 - 122,400; Full time

Job summary

A leading medical device company in Bloomington, Minnesota is seeking a full-time Sr. Quality Engineer to provide quality assurance support for manufacturing. Responsibilities include developing inspection methods, acting as the quality interface for production, and conducting internal audits. The ideal candidate will have a Bachelor's degree, 10 years of experience, and strong leadership skills. This role offers competitive pay and a collaborative work environment.

Qualifications

• 10+ years of experience in a regulated industry manufacturing setting.
• Knowledge of quality systems and regulatory requirements.
• Ability to achieve business results.

Responsibilities

• Develop and execute inspection methods and protocols.
• Act as the quality interface for a production team.
• Conduct internal and support external audits.

Skills

Leadership skills

Attention to detail

Verbal and written communication skills

ERP and quality systems experience

Team environment collaboration

Education

Bachelor's Degree in Mechanical, Industrial, or related field

Tools

Microsoft Office

Job description

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QTS Medical Device Outsourcing provided pay range

This range is provided by QTS Medical Device Outsourcing. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$97,900.00/yr - $122,400.00/yr

About QTS

QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at www.qtspackaging.com and www.cretexmedical.com.

Senior Quality Engineer

Senior Quality Engineer Ideal Candidate Profile

QTS is currently seeking an experienced, energetic, responsive and well-organized full-time Sr. Quality Engineer who will be responsible for providing quality assurance support for manufacturing. This position will also be responsible for the definition, implementation, and improvement of quality related practices and will provide technical guidance and measurement methodologies support.

Senior Quality Engineer Job Summary

• Customer facing quality representative for the development project, complaints, and customer feedback.
• Develop and execute inspection methods; TMV/MSA protocols and reports, facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document such as control plans and inspection documents and plans.
• Act as the quality interface for a production team in responding to customer complaints using failure analysis, development of corrective and preventative actions and trend analysis.
• Conduct internal audits, support external audits by regulatory bodies and customers, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions.
• Coach and mentor Quality Engineer levels, I, II, and III.
• Subject matter expert in one or more areas of the ASQ (American Society for Quality) QE BOK (Body of Knowledge).
• Lead and participate in large company-wide projects providing quality recommendations.
• Partner with sister companies to implement best practices.
• Support validation activity of processes, equipment, and metrology.
• Ensure business systems are implemented, maintained, and functioning properly.

Senior Quality Engineer Skills and Experience

• Bachelor's Degree in Mechanical, Industrial, or in another Engineering or Physical Science.
• 10 years of experience in engineering in a regulated industry manufacturing setting.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Ability to consistently achieve short and long-term business results.
• Demonstrate leadership skills.
• Experience with ERP and quality systems.
• Clear and effective verbal and written communication skills.
• High attention to detail and good organizational skills.
• Ability to work in a fast-paced team environment.

Desirable Criteria & Qualifications

• Continuing Education; including participation in local chapters, associations, and/or organizations.

What Is It Like to Work for QTS?

At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of things that employees have said about working at QTS:

• "I would describe my coworkers as kind and friendly."
• "… I interned at QTS, then I went back to school… I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good, fun ride so far and I can't wait to keep it going!"
• "Three words that I would use to describe QTS's culture are: Respectful, Fast-paced, and Fun!"

We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member.

About QTS

QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at www.qtspackaging.com and www.cretexmedical.com.

Senior Quality Engineer

Senior Quality Engineer Ideal Candidate Profile

QTS is currently seeking an experienced, energetic, responsive and well-organized full-time Sr. Quality Engineer who will be responsible for providing quality assurance support for manufacturing. This position will also be responsible for the definition, implementation, and improvement of quality related practices and will provide technical guidance and measurement methodologies support.

Senior Quality Engineer Job Summary

• Customer facing quality representative for the development project, complaints, and customer feedback.
• Develop and execute inspection methods; TMV/MSA protocols and reports, facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document such as control plans and inspection documents and plans.
• Act as the quality interface for a production team in responding to customer complaints using failure analysis, development of corrective and preventative actions and trend analysis.
• Conduct internal audits, support external audits by regulatory bodies and customers, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions.
• Coach and mentor Quality Engineer levels, I, II, and III.
• Subject matter expert in one or more areas of the ASQ (American Society for Quality) QE BOK (Body of Knowledge).
• Lead and participate in large company-wide projects providing quality recommendations.
• Partner with sister companies to implement best practices.
• Support validation activity of processes, equipment, and metrology.
• Ensure business systems are implemented, maintained, and functioning properly.

Senior Quality Engineer Skills and Experience

• Bachelor's Degree in Mechanical, Industrial, or in another Engineering or Physical Science.
• 10 years of experience in engineering in a regulated industry manufacturing setting.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Ability to consistently achieve short and long-term business results.
• Demonstrate leadership skills.
• Experience with ERP and quality systems.
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
• Clear and effective verbal and written communication skills.
• High attention to detail and good organizational skills.
• Ability to work in a fast-paced team environment.

Desirable Criteria & Qualifications

• Continuing Education; including participation in local chapters, associations, and/or organizations.

What Is It Like to Work for QTS?

At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of things that employees have said about working at QTS:

• "I would describe my coworkers as kind and friendly."

• "… I interned at QTS, then I went back to school… I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good, fun ride so far and I can't wait to keep it going!"

• "Three words that I would use to describe QTS's culture are: Respectful, Fast-paced, and Fun!"

We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member.

Desired Skills and Experience

10+ years engineering experience in a regulated industry manufacturing setting.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering, Production, and Quality Assurance

• Industries

  Manufacturing and Medical Equipment Manufacturing

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