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Quality Auditor – Join Our Team!

Drive Excellence and Compliance in Medical Devices

Are you ready to make a significant impact on patient safety and product quality? We are seeking a dedicated Quality Auditor to help elevate our quality management system (QMS) and ensure compliance with industry-leading standards, including ISO 13485, MDSAP, EU MDR, and more. If you have a passion for quality in medical device manufacturing, we want to hear from you!

Key Responsibilities:

+ Plan and schedule internal audits, including the development of audit checklists and criteria.

+ Interview personnel, review documentation, and observe operations to assess adherence to quality requirements.

+ Identify and document non-conformities and opportunities for improvement in detailed internal audit reports.

+ Collaborate with cross-functional teams to drive timely and effective corrective actions.

+ Support the QA team in managing CAPAs and hosting external audits.

+ Stay current with evolving regulatory requirements and industry standards.

What we’re looking for in you:

+ Bachelor’s degree in a scientific, engineering, or related field.

+ Familiarity with medical device development, manufacturing, or testing processes.

+ Working knowledge of cGMP, ISO 13485, MDSAP, EU MDR, and FDA 21 CFR Part 820.

+ Strong analytical, organizational, and verbal communication skills.

+ Proficient in technical writing and documentation.

+ Ability to work independently and manage multiple priorities effectively.

+ Proficient in MS Office (Outlook, Word, Excel, and PowerPoint).

+ Preferred: Certified Quality Auditor (CQA) or ISO 13485:2016 Certified Lead Auditor Training.

+ Preferred: 1–2 years of internal or external auditing experience within a Class II or higher medical device environment.

Why Join Ultradent?

+ Be part of an innovative company making a difference in oral care.

+ Grow your career in a dynamic and supportive environment.

+ Collaborate with talented professionals committed to quality and safety.

+ Competitive compensation and benefits package.

If you are detail-oriented, driven by a commitment to quality, and eager to contribute to the advancement of life-saving medical devices, we invite you to apply for the Quality Auditor position!

Ultradent is an Equal Opportunity Employer. We are a global culture where differences and perspectives are sought after, welcomed, and embraced. We consider all qualified applicants fairly, based on their experience, skills, and potential to contribute to our team. Our core values – Integrity, care, quality, innovation, and hard work- guide us daily. These values, when balanced, shape our workplace culture and ensure that we remain focused on our vision while maintaining a professional and inclusive environment.  VEVRAA Federal Contractor: For more information please contact us at [email protected]

WHY WORK AT ULTRADENT:

Ultradent Products, Inc., is a collaborative and hard-working company with a 45-year history of innovation. Ours is a fun, fast-paced work environment dedicated to providing unique, solution-oriented products to dentists—and their patients—across the globe. Our company was built on a foundation of innovation, integrity, hard work, quality, and care, and we put those values into everything we do. We ask all colleagues to seek out the excluded, enhance the team, share feedback fearlessly, welcome feedback humbly, amplify all voices, and embrace our differences. Hear what some of our employees have to say #whyiultradent : https://youtu.be/UGpDHCaZ\_Yw.

WHAT BENEFITS AND PERKS YOU'LL GET AT ULTRADENT:

+ Medical/Dental & Other Insurances (eligible the first of month after 60 days)

+ Health Savings Account with employer contribution

+ 401K Plan with employer matching contribution

+ Employee access to discounted Ultradent products

+ Excellent Paid Time Off (PTO) and Medical Time Off (MTO) account to support medical and military events

+ Five days paid between Christmas and New Years

+ Education Assistance

+ Onsite Fitness Center