Quality Assurance Specialist, Sr

A-dec, Inc. (USA); Newberg (OR); On-site; USD 80,000 - 100,000; Full time

Job summary

A-dec, Inc. in Newberg, Oregon, is seeking a Senior Quality Assurance Specialist responsible for maintaining compliance with Quality Management System (QMS) standards in the medical device sector. The successful candidate will manage internal audits, liaise with third-party inspectors, and ensure efficient business processes.

Applicants should have a Bachelor's degree and at least four years of relevant experience, demonstrating strong project management skills and a profound understanding of international medical device regulations.

Qualifications

• At least 4 years of experience in a QMS administrator role.
• Demonstrated knowledge of medical device regulations.
• Experience as a lead internal auditor is preferred.

Responsibilities

• Coordinate A-dec’s Quality Management System in compliance with regulations.
• Manage internal audit processes and lead audit teams.
• Organize third-party audits and provide training on quality topics.

Skills

Proficient in Microsoft Office

Attention to detail

Strong technical writing

Project management

Statistical analysis

Quality measurement

Education

Bachelor’s degree in business, science, or engineering

Tools

eQMS software platforms

Job description

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. The role involves routine administration of processes, leading internal audits, liaising with third‑party auditors/inspectors, and partnering across the organization to ensure efficient, compliant business processes.

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.
• Travel to audits as 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 third‑party audits and inspections, as needed.
• Supports the Management Representative with key QMS processes, including Management Review.
• Participates as process administrator for the 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 to continually improve and enhance the QMS.
• Coaches and mentors Quality Assurance Specialists 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.
• Achieves and maintains deep technical understanding of ISO13485, 21CFR820, EUMDR and other medical device quality management and regulatory compliance standards as applicable.
• Minimum 50% campus based; full remote is not an option due to manufacturing facility‑based activities.

Qualifications

• 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, and 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.

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, ISO13485, MDSAP) applicable to classI 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.

Equal Employment Opportunity

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.