Quality Assurance Specialist, Sr

Quality Assurance Specialist, Sr page is loaded## Quality Assurance Specialist, Srremote type:
Hybrid locations:
Oregon - Newberg Campus time type:
Full time posted on:
Posted 6 Days Agojob requisition :
JR101956

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.
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* 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.
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* 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.
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