Quality Assurance Specialist, Sr

About the role

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.

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.