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Quality Systems Specialist

4 weeks ago


Minneapolis, Minnesota, United States Quality Tech Services, LLC Full time

About QTS

Quality Tech Services, LLC is a leading provider of critical end-of-line services for medical device OEMs. Our company offers finished device assembly, packaging, and sterilization management services. As part of the Cretex Medical family of companies, we are committed to delivering high-quality services that meet the needs of our customers.

Job Summary

We are seeking a highly motivated and organized Quality Systems Specialist to join our team. The successful candidate will be responsible for developing, implementing, and maintaining our quality management system. This includes leading second and third-party audits, managing the internal audit program, and performing process and product audits to identify gaps and deficiencies.

Key Responsibilities

  • Lead second and third-party audits, including audit preparation, execution, reporting, and follow-up activities.
  • Manage the internal audit program, including the selection and training of the internal audit group and the implementation of effective corrective actions.
  • Perform process and product audits to identify gaps and deficiencies and implement process improvement initiatives using lean techniques.
  • Provide leadership in company regulatory matters and support customers regarding their regulatory needs.
  • Develop and maintain a global quality system model that scales with organizational growth.
  • Support, lead, and coordinate supplier audits.
  • Implement, monitor, lead, and assist corrective and preventive actions (CAPAs) that result from second, third-party, and internal audits.
  • Identify, develop, and maintain relevant QMS training programs to promote quality awareness and ensure compliance to company policies and procedures.
  • Partner with quality and operations to implement quality system improvements.
  • Implement, maintain, and provide issue resolution in regard to the global quality system software.
  • Support and comply with the company quality system, ISO, and medical device requirements.
  • Partner with document control team to ensure compliance to quality system and regulatory requirements.

Qualifications

  • Bachelor's degree in a related field.
  • 3 years of experience working with quality management systems.
  • Experience with ISO 13485:2016 and FDA.
  • Lead Auditor Certification.
  • Front room audit experience for external and third-party audits.
  • Ability to consistently achieve short- and long-term business results.
  • Ability to prioritize work and manage multiple tasks when needed.
  • Ability to follow through on commitments and hold team members accountable.
  • Consistently produces work that meets the customers' requirements.
  • Focus on Operational Excellence.
  • Project management skills.
  • Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
  • Clear and effective verbal and written communication skills.
  • Attention to detail and organizational skills.
  • Ability to work in a fast-paced team environment.
  • Ability to prioritize and multitask.
  • Ability to work in a manufacturing environment.
  • Ability to travel up to 15%.

Desirable Criteria & Qualifications

  • Quality systems experience in a manufacturing setting.
  • 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. We pride ourselves on our culture and work environment. Here are some 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.

QTS Benefits

As a Cretex Medical company, QTS offers a full benefit package to its employees. Benefits include medical, dental, vision, and life insurance options. QTS also offers a 401(k) retirement plan with employer match, profit sharing, short- and long-term disability insurance, paid time off, and holiday pay.

QTS also offers company-specific benefits, such as:

  • Free Parking
  • Employee Appreciation Events
  • Volunteer Opportunities
  • Training and Development opportunities
  • Tuition Reimbursement
  • Annual Flu Vaccination Clinics

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit