Quality Engineering Manager

Department: Quality Assurance
Reports to: Global Director Quality Assurance
FLSA Status: Exempt

SUMMARY

The Quality Engineering Manager assumes responsibility for management and technical leadership of Quality Engineering and Quality Control at the Apyx Medical Clearwater, Florida site. The position is responsible for ensuring timely and effective implementation of all company’s policies, procedures, and activities involved in assuring the quality of product design and development, risk management, supply chain, and manufacturing processes. The role maintains close working relationships with other department managers and supervisory personnel in order to meet and maintain product quality, identify, solve and prevent problems affecting product quality, maximize productivity, and comply with regulatory requirements. The Quality Engineering Manager provides quality support for the Business to ensure that the quality of the raw materials received and products manufactured meet defined product specifications through review of manufacturing data and trends, review of nonconformance trends, suitability of manufacturing controls and raw material inspections in a timely manner. Assist in the investigation of manufacturing and quality program issues and supplier nonconformances in support of the Business.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

General Supervision – Quality Engineering and Quality Control Support

  • Supervise quality engineers who are responsible for design assurance, risk management, supplier quality assurance, sustaining quality, validation, and support of manufacturing.
  • Supervise quality assurance technicians/inspectors who are responsible for inspection, calibration, and environmental monitoring.
  • Maintain a fair and professional work environment that focuses the business objectives, but also balances quality of work-life factors for employees.
  • Ensure good performance by quality assurance technicians/inspectors and engineers by mentoring, training, setting expectations, providing accountability, and performing evaluations.
  • Participate in regulatory, third party and customer audits and inspections, and corrective action response, as needed.
  • Participate in the internal quality auditing program as an auditor for other functional areas within the Quality System, as requested.
  • Assist Global Director, Quality Assurance with special projects and other duties, as assigned.

Quality Assurance

  • Develop and implement systems, procedures, and practices as to achieve planned quality objectives.
  • Ensure that Quality System level procedures exist and are maintained for change management, validation, sterilization program, supplier quality, production, production control, calibration, inspection, and equipment/fixture maintenance.
  • Assist in the implementation of policies, operating procedures, quality systems and programs which ensure proper testing, evaluation, inspection, and technical support in order to meet product quality standards.
  • Assist in maintaining and improving Quality Management System documentation (internal procedures, quality manual, etc.), as identified, including writing procedures.
  • Implement and apply continuous process improvements through the use of lean manufacturing, six sigma or other techniques to enhance manufacturing quality, reliability, or cost-effectiveness.

Non-conformance Program and Quality Metrics

  • Supervise the non-conformance program to ensure timely opening, investigation, closure and trending of non-conformities related to manufacturing.
  • Provide actionable non-conformance trending for data review and Management review meetings and proactively address negative trends, as they emerge. Perform weekly and monthly data analysis of all nonconforming product/quality issues.
  • Assist in investigating and correcting manufacturing quality-related issues (including customer complaints) through collaboration with other departments.
  • 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, as required.

EDUCATION AND EXPERIENCE

Bachelor’s Degree preferred from an accredited College or University and/or five (5) or more years of quality/process/manufacturing experience; At least 3 years of supervisory experience required. 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.
  • Advanced computer knowledge (Microsoft Office applications and Excel data analysis) and computer-based applications.
  • Knowledge of using test equipment and measurement tool and interpreting the data’s outcome.
  • Knowledge of 21 CFR Part 820, ISO 13485:2016, MDSAP, and EU MDR. \
  • Excellent time management, prioritization skills and ability to meet multiple deadlines in fast passed environment
  • Effective written and verbal communication skills
  • ASQ Auditor Certification or ISO 13485:2016 Auditor Certification preferred.

CRITICAL COMPETENCIES

  • Strong problem-solving skills and initiative. 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.
  • Ability to adapt to changing organizational and operational needs; ability to lead others through change.
  • Ability to handle multiple tasks simultaneously; Skill in organization and prioritization, and attention to detail.
  • Strong team player and leader with the ability to work across multiple functions and disciplines; Must be able to effectively communicate ideas (verbally and in writing), be a self-starter and handle difficult reporting situations.
  • The ability to perform at high levels in a fast-paced, dynamic environment.

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.

Please forward your resume, along with your salary requirements to: Human Resources, Apyx Medical Corporation, 5115 Ulmerton Road, Clearwater, FL 33760 or email 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

Human Resources
Apyx Medical Corporation
5115 Ulmerton Road
Clearwater, FL 33760-4004

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