A-dec Inc. · 7 hours ago
Quality Assurance Specialist, Sr
Newberg, OR
Full-time
Onsite
Mid, Senior Level
4+ years expA-dec Inc. is dedicated to creating high-quality products and services for the dental industry while providing a rewarding employment experience. The Senior Quality Assurance Specialist will coordinate and maintain the Quality Management System in compliance with medical device regulations, lead internal audits, and support continuous improvement initiatives across business functions.
HardwareHealth CareManufacturing
No H1B
Responsibilities
Acts as technical subject matter expert for internal stakeholder groups on QMS processes, procedures, and governance to ensure spirit, intent and compliance is achieved and sustained
Manages the internal audit process, leading audit teams and acting as a lead internal auditor, for QMS internal audits for a multi-site operation. Occasional travel for audits is required (approximately up to 5 business days per year)
Analyzes audit results and provides direction for necessary corrective action related to process issues. Continuously improves internal audit methods to ensure A-dec quality system standards are maintained
Organizes, facilitates, and chaperones 3rd party audits and inspections, as needed
Supports Management Representative with key QMS processes, including Management Review
Participates as process administrator for weekly customer complaints review process (FACT -Feedback and Complaints Team) in collaboration with QA Engineers and other stakeholder groups
Participates as process administrator for monthly CAPA Review Board meetings in collaboration with QA Engineers and other stakeholder groups
Identifies and implements continuous improvement initiatives as needed, to continually improve and enhance the QMS
Coaches and mentors Quality Assurance Specialist(s) to grow capabilities and technical acumen
Assists in developing and delivering training for the company on a wide variety of quality topics. Provides supplemental required training for auditing and coordinates professional training as a requisite for new team members, as needed
Achieves and maintains deep technical understanding of ISO 13485, 21 CFR 820, EU MDR and other medical device quality management and regulatory compliance standards as applicable
Other duties as assigned
Qualification
Required
Bachelor's degree in business, science, or engineering field, or equivalent experience
At least four years of experience in a QMS administrator role with demonstrated working knowledge of federal / international medical device regulations, guidance, and standards (e.g., FDA, CMDR, EUMDR, ISO 13485, MDSAP) applicable to class I and II medical devices
Proficient in Microsoft Office with ability to create, edit, and optimize electronic documents, including spreadsheets and database reports
Impeccable attention to detail, strong organizational skills, along with the ability to accurately interpret policies and practices
Strong technical writing and overall communication skills
Proven ability to lead multi-year projects and meet project deadlines both independently and as part of a team
Skilled in project management, statistical analysis, root cause analysis, quality measurement, continuous improvement, and database applications
Ability to successfully organize and lead cross-functional project teams; communicate effectively, including presentations to stakeholders including executive leadership
Minimum 50% campus based. Fully remote is not an option due to manufacturing facility-based activities
Preferred
Familiarity with enterprise quality management system (eQMS) software platforms, digital workflows, document & record control best practices
Experience as lead internal auditor of Quality Management Systems
Benefits
Inclusive culture
Total well-being
Opportunities for learning and career advancement
Company
A-dec Inc.
Innovation. Creativity. Evolution. If these are words you’re passionate about, we should chat.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Michael J. Highland
Chief Financial Officer
Travis Morgan
HR Business Partner - Manufacturing
Recent News
Seattle TechFlash
2025-09-09
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