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.
- 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.
- 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]
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What We Do
Ultradent Products, Inc., is a leading developer of high-tech dental materials, devices, and instruments worldwide. Ultradent’s mission is to improve the level of dental health care and to make dental procedures more predictable and efficient. Consistent with its mission, Ultradent works to improve the quality of life and the health of individuals through financial and charitable programs.
Ultradent evolved from a dentist’s quest to create more effective dental products. Dr. Dan Fischer's desire to develop more advanced dental products led him to create products that would set future industry standards.
Today, Ultradent has subsidiaries in Germany, Italy, Brazil, Spain, Malaysia, China, and Japan, employing approximately 1,900 individuals and manufacturing and packaging more than 500 materials, devices, and instruments. While Ultradent has expanded into a worldwide company, the majority of its professional and skilled manufacturing positions have remained in the United States, providing jobs for a diverse community of Americans. Ultradent is committed to local production and is proud to be a USA manufacturer.
Ultradent’s products are used worldwide by dentists, group practices, dental and veterinary labs, government agencies, and universities. Ultradent has continued its development efforts, holding dozens of patents and trademarks on unique products, materials, devices, and application techniques
