What are the responsibilities and job description for the Quality Assurance Auditor position at Ultradent Products Inc.?
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 Recruiting@ultradent.com
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