Quality Assurance Specialist, Sr

Regulatory Jobs; Newberg (OR); On-site; USD 90,000 - 120,000; Full time

Job summary

A-dec is seeking a Senior Quality Assurance Specialist to coordinate A-dec's QMS, ensuring audit readiness and compliance with US FDA, EU MDR, and ISO 13485 standards. You will lead internal audits, coordinate third-party inspections, and drive CAPA and improvement initiatives across a multi-site operation.

The role requires strong technical writing, cross-functional collaboration, and the ability to mentor junior QA staff. Some travel is expected for audits.

Qualifications

• Bachelor’s degree in science, engineering, or related field.
• Minimum four years in a QMS administrator role with knowledge of FDA, CMDR, EU MDR, ISO 13485, MDSAP.
• Experience as lead internal auditor preferred.

Responsibilities

• Lead internal audits for a multi-site operation and coordinate audit teams.
• Analyze audit results and drive CAPA and process improvements.
• Facilitate third-party audits and inspections as needed.
• Support Management Representative with key QMS processes.
• Oversee weekly customer complaints review and CAPA boards.

Skills

QMS administration

Internal auditing

CAPA management

Regulatory knowledge

FDA regulations

ISO 13485

Project management

Technical writing

Cross-functional leadership

Data analysis

eQMS software

MS Office

Education

Bachelor’s degree in science/engineering

4+ years QMS admin experience

Lead internal auditor experience

Tools

eQMS software

MS Office

Job description

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.

Overview

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.

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.