Quality Assurance Specialist, Sr

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.

• 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 ISO
  13485, 21
  
  CFR
  820, 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.

• 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.

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.

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.

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.