Sr. Quality Assurance Auditor

Department: Quality Assurance
Reports to: Quality Assurance Supervisor
Status: Exempt

SUMMARY

The Sr. Quality Assurance Auditor provides quality support for the Business to ensure that the quality of the raw materials received and products manufactured meet defined product specifications through defined inspections. Assist in the investigation of manufacturing issues and supplier nonconformances in support of the Business, including the use of test equipment and inspection techniques. Responsible for performing data analysis for monthly metric reporting of quality-related data.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

  • Perform routine dimensional, visual, or functional inspections of the Production process and product (in-process and finished goods) to ensure quality compliance to defined specifications and associated Device History Record (DHR).
  • Perform dimensional, visual, and functional inspections of incoming materials using several measuring equipment including the automatic measuring systems.
  • Perform inspections to support new product development and manufacturing validation testing, including first article Inspections.
  • Perform routine quality audits of manufacturing area to ensure material identification, traceability, equipment calibration, product assemblies, etc. meet requirements.
  • Ability to use mechanical, electronic and automatic test equipment and analyze results based on established product specifications. Perform test method validations by following appropriate Apyx Medical procedures.
  • Perform root cause analysis of non-conforming product with Quality, Production, and Engineering leadership using established tools and principles, track corrective actions, and ensure closure of nonconformances to meet monthly metrics.
  • Accurately interpret inspection procedures, test methods, and inspection standards to ensure product meets defined specifications.
  • Assist in creating, maintaining, and improving Quality Management System documentation (internal procedures, quality manual, etc.), as identified, including writing procedures.
  • Generate and manage nonconformance reports using system database.
  • Perform weekly and monthly data analysis of all nonconforming product/quality issues. Track and maintain quality results for appropriate distribution.
  • Lead or support process improvement activities, CAPA investigations, and Kaizen events in Production and Incoming Inspection.
  • Interface with Supplier Quality Engineer, compliance, and other representatives on quality concerns, quality trends, and other associated issues.
  • Review device history records (DHR) and quality-related documents for accuracy and completeness.
  • Perform internal audits, as requested.
  • Supports quality team during regulatory and customer audits.
  • Assist and/or train staff in supporting the Quality Management Systems, as needed, including Production auditing and in measurement techniques.
  • Assist Quality Engineering team with special projects and other duties, as assigned.
  • Prioritize and manage multiple project/tasks.
  • Assist in Environmental monitoring, as needed.
  • Oversee outsourced calibration.

EDUCATION & EXPERIENCE

Bachelor’s Degree from an accredited College or University and/or five (5) or more years of quality/process/manufacturing experience. 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 using test equipment and measurement tool and interpreting the data’s outcome.
  • Knowledge of 21 CFR Part 820, ISO 13485:2016, MDSAP, MDD 93/42/EEC.
  • Experience with technical writing preferred.
  • ASQ Auditor Certification is a plus.

CRITICAL COMPENTENCIES

  • 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 and absolute discretion.

Join the team where we offer a rewarding work experience, compensation and benefits package. Salary is commensurate with professional experience. For immediate consideration, please forward your resume, along with salary requirements, to: Asanka Abeyratne, Apyx Medical Corporation, 5115 Ulmerton Road, Clearwater, FL 33760-4004 or e-mail HR@apyxmedical.com.

APPLYING FOR EMPLOYMENT

If you are interested in becoming a member of the Apyx Medical team, you may download our Employment Application PDF, fill it out, and send it along with your resume using any of the following methods:

EMAIL OUR HUMAN
RESOURCES DEPARTMENT

HR@apyxmedical.com

MAIL A HARD COPY

Asanka Abeyratne
c/o Apyx Medical Corporation
5115 Ulmerton Road
Clearwater, FL 33760-4004

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