Sr. Quality Assurance Auditor
Department: Quality Assurance
Reports to: Quality Systems Manager
The Sr. Quality Assurance Auditor provides quality support for the Business through the execution of the Company’s internal audit program and support for external audits where required. The Sr. Quality Assurance Auditor reviews that the quality compliance of the manufacturing processes and processes supporting manufacturing. Responsible for performing data analysis for monthly metric reporting of quality-related data.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
- Responsible for the execution of all Quality Management System and In-Process audits of the Clearwater, FL site.
- Perform audits of all aspects of the Quality Management System per the audit schedule to ensure all systems are in compliance with the required standards and regulations.
- Perform routine In-Process quality audits per the audit schedule of manufacturing area to ensure material identification, traceability, equipment calibration, product assemblies, etc. meet requirements.
- Develop and maintain audit checklists for internal audit topics based on the relevant audit criteria.
- Generate and distribute audit reports and communicate results to stakeholders.
- Perform risk analysis on identified nonconformities and assign nonconformance reports (NCRs) and/or CAPAs accordingly.
- Communicate Quality KPIs for the Internal Audit Program to Quality Systems for monthly metric reporting and Management Review.
- Assist in creating, maintaining, and improving Quality Management System documentation (internal procedures, quality manual, etc.), as identified, including writing procedures.
- Lead or support process improvement activities, CAPA investigations, and Kaizen events within the Quality Systems team
- Interface with Supplier Quality, Quality Engineering, and other representatives on quality concerns, quality trends, and other associated issues.
- Supports quality team during regulatory and customer audits.
- Assist and/or train staff in supporting the Quality Management Systems, as needed, including Quality System and In-Process auditing.
- Aid in the qualification of others for internal auditing.
- Assist Quality Systems, Quality Engineering, and/or Manufacturing Quality teams with special projects and other duties, as assigned.
- Perform external audits of suppliers, distributors, and/or service providers as required.
- Prioritize and manage multiple project/tasks.
EDUCATION AND EXPERIENCE
Bachelor’s Degree from an accredited College or University and/or five (5) or more years of quality assurance and/or compliance experience within a regulated industry. This candidate should have skills in the following areas:
- Experience utilizing and applying Quality Tools to solve problems: FMEA, CAPA, Root Cause Analysis, DMAIC, etc.
- Knowledge of 21 CFR Part 820, ISO 13485:2016, MDSAP, EU MDR.
- Experience with technical writing preferred.
- ASQ Certified Quality Auditor or Certified ISO 13485:2016 auditor preferred.
- Strong problem-solving skills. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an expansive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Attention to detail, thoroughness, and dealing with complexity.
- The ability to perform at high levels in a fast-paced, dynamic environment.
- Proficient in MS Office (Word, Excel, PowerPoint).
EMPLOYMENT WITH APYX MEDICAL
All employment with Apyx Medical is considered employment-at-will. Employment-at-will means that either party can sever the employment at any time for any reason. Additionally, the responsibilities and functions outlined in the description may be changed or modified at any time by Apyx Medical in response to its changing needs and at its sole absolute discretion.
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