Quality Assurance Specialist, Sr

A-dec Inc.; Newberg (OR); Hybrid; USD 95,000 - 130,000; Full time

Job summary

A leading dental products company is seeking a Senior Quality Assurance Specialist to manage the Quality Management System and lead internal audits. The role requires at least four years of experience in a QMS administrator role and familiarity with medical device regulations. Successful candidates will demonstrate proficiency in Microsoft Office, technical writing, and project management. The position is hybrid based in Oregon, offering a chance to contribute to high-quality standards in the industry through continuous improvement initiatives.

Qualifications

• At least four years of experience in a QMS administrator role.
• Demonstrated knowledge of medical device regulations.
• Experience as lead internal auditor preferred.
• Strong knowledge of FDA, CMDR, EUMDR, ISO 13485, and MDSAP requirements.

Responsibilities

• Coordination and maintenance of QMS.
• Lead internal audits for multi-site operation.
• Provide training on quality topics.
• Facilitates weekly complaint reviews and monthly CAPA boards with QA teams.
• Mentors QA staff and supports QMS training and development.

Skills

Microsoft Office proficiency

Attention to detail

Technical writing

Project management

Statistical analysis

Quality measurement

Documentation control

Communication

Education

Bachelor's degree in business, science, or engineering

Tools

eQMS software

MS Office

Job description

Quality Assurance Specialist, Sr page is loaded## Quality Assurance Specialist, Srremote type: Hybridlocations: Oregon - Newberg Campustime type: Full timeposted on: Posted 6 Days Agojob requisition id: JR101956At 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.## OverviewThe 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.**JOB DUTIES AND 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.**QUALIFICATIONS:****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.**Education and Experience*** 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.**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.*You are a dreamer. A doer. The one who never stops seeking a better way. You are the kind of person we are looking for to join our team.If you know A-dec, you know that we are a global, family-run company with a big name in the dental industry. But we didn’t get here by settling for the status quo. We are perpetually pursuing ways to improve our products and consequently, the lives and well-being of our doctors and patients. A-dec encourages collaboration, believing that curiosity leads to innovation, and diversity and cross-function create the unexpected. We work hard. We play hard. And we never forget that the time you balance outside of work shapes and defines you as a person.Let's make a difference together.