Quality Assurance Specialist, Sr

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

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 ISOCFR 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

• Bachelors 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 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.