New · posted Oct 15
A-dec · Medical Devices
Quality Assurance Specialist, Sr
- Newberg, OR
- Hybrid
- Full-time
- Senior & Principal
Open until filled
The role
The Senior Quality Assurance Specialist is responsible for coordinating, organizing, and maintaining aspects of A-dec’s Quality Management System (QMS) in a state of audit readiness and compliance with Medical Device regulations and standards including US-FDA, Health Canada, and the European Union, via routine administration of processes, including leading internal audits, liaison with third party auditors/ inspectors and other internal stakeholders as part of the Quality & OpEx team. The position provides a lead role in execution of key Quality processes (including CAPA & Audit Programs) and partners across business functions to ensure efficient, compliant business processes and environment.
At A-dec, we do more than create the highest quality products and services for the dental industry; we strive to deliver a superior employment experience for each of our team members. With an environment that encourages and assists each person in developing to their highest potential, a career at A-dec is incredibly rewarding.
What you need
- 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.
- Experience as lead internal auditor of Quality Management Systems preferred.
Knowledge, Skills, and Abilities
- 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.
- Familiarity with enterprise quality management system (eQMS) software platforms, digital workflows, document & record control best practices preferred.
- Minimum 50% campus based. Fully remote is not an option due to manufacturing facility-based activities.
Skills named in this posting
What you'll do
- 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.
Where you'll work
Newberg, ORHybridOpen in Maps (opens in a new tab)
More jobs in Newberg, OREqual opportunity, accessibility and legal noticesA-dec's statements, word for word
Disclaimer
This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not to be construed as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. A-dec reserves the right to assign job duties and days and hours of work based on factors such as workload requirements, staffing levels, and customer demands.
At A-dec, we value our people and show it by prioritizing an inclusive culture, total well-being, and opportunities for learning and career advancement.
A background check and screen for the illegal use of drugs is required.
A-dec is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. In addition, A-dec will not discriminate against applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another. *VEVRAA Federal Contractor”
A-dec is interested in qualified candidates authorized to work in the United States for US-based positions. We are unable to sponsor or take over sponsorship of employment visas.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $103,375 | $122,750 | $137,500 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not A-dec's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership12
- Quality systems and risk11
- GMP and compliance9
- Documentation and SOPs4
- Investigations and CAPA4
- Data and digital systems2
- Lab testing and methods1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDA and partnersMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program
Company hiring pulse
A-dec on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 1
- Locations
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Quality Assurance Specialist, Sr at A-dec
Open until filled.