Quality Assurance Specialist, Sr

A-dec•Newberg, OR

3d•Onsite

About The Position

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.

Requirements

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.
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.
Minimum 50% campus based. Fully remote is not an option due to manufacturing facility-based activities.

Nice To Haves

Experience as lead internal auditor of Quality Management Systems preferred.
Familiarity with enterprise quality management system (eQMS) software platforms, digital workflows, document & record control best practices preferred.

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.