Quality Systems Manager
Department: Quality Assurance
Reports to: Global Director, Quality Assurance
FLSA Status: Exempt
The Quality Systems Manager assumes responsibility for management and technical leadership for the development and management of Apyx Medical Corporation quality systems, including but not limited to CAPA, non-conforming materials, internal audit program, external audits (i.e. FDA, Customer Audits, Notify Body Audits), document control, quality records, management reviews, and training programs. This position requires experience developing, implementing, and managing Quality Systems; and the ability to perform at high levels in a fast-paced, dynamic environment.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Lead Quality Systems team in execution of daily activities in support of operations, R&D, Regulatory Affairs, and Quality Assurance.
- Establish and execute team goals for the department in support of strategic organizational initiatives.
- Develop and implement systems, procedures and practices to sustain the Quality Management System in line with the required industry standards, accreditation requirements and business requirements across the organization.
- Regulate, control and improve the quality of all processes throughout the business and the final product. Manage the internal audit program and ensure that all nonconformities raised by certification bodies during audits are effectively corrected and independently verified. Manage the Corrective and Preventive Action (CAPA) system.
- Responsible for the identification and interpretation of applicable international and domestic regulations and standards – ensure that Product Development integrates these requirements to product designs.
- Schedule and coordinate Management Review Meetings and follow-up to ensure that action items are completed.
- Serve as the primary interface for all inspections and audits of in-process quality management, internal audits and CAPA. Manage ongoing continuous improvement initiatives.
- As an integral member of the Quality team, this position ensures all quality system elements are implemented, compliant, effective, and efficient to meet the current and future needs of the Company sites and facilities.
- Oversee partnership with CAPA owners to ensure various CAPA elements (investigations, root cause determination, implementation, and effectiveness) are adequately documented and addressed while ensuring timely completion of all CAPA activities.
- Prepare and maintain an annual Internal Audit Schedule and corresponding Internal Audit reports.
- Oversee partnership with auditees to ensure the timely completion of actions related to audit findings (including any CAPAs resulting from an Internal Audit).
- Maintain the company’s controlled documents and quality records, including external reference standards and documents to ensure accuracy and accessibility to controlled document both internally and externally.
- Collaborate with department managers to ensure Training Plans are prepared for all new hires and updated as appropriate for current employees.
- Measure, monitor, and report metrics on all the systems listed above to ensure system effectiveness and efficiency and implement updates/changes as necessary to meet changing business needs.
- Develop, establish, monitor, and report on both corporate and departmental quality objectives, metrics, and goals. Track and trend quality data from multiple feeder systems throughout the organization to determine trends, escalation triggers and improvement actions. Develop and issue Data Review presentations to ensure Apyx Medical’s leadership is informed of the Quality Systems performance and Apyx Medical’s employees are aware of their deliverables within the Quality System at all times.
- Oversee Management Review meetings and assist with gathering, preparing, analyzing, and presenting data to executive management on the performance of the Quality Management System.
- Interact and interface with various government agencies, private companies, and consultants related to Quality System audits/inspections and assist with the timely response to any findings.
- Promote and ensure companywide quality system compliance with all applicable national and international standards and regulations.
- Support quality system integration and adoption activities across all Apyx Medical sites.
- Embed a culture of continuous improvement throughout the company. Lead the team to achieve quality management system targets for customers and business goals.
- Create and revise Standard Operating Procedures consistent with GMP, ISO, MDSAP, MDR and other regulatory requirements.
- Other duties as assigned from time to time.
EDUCATION AND EXPERIENCE
- Bachelor’s degree from a four-year College or University. Degree in Engineering, Sciences, or similar field preferred.
- 5+ years’ working in the medical device or FDA regulated industry.
- 5+ years’ working with QMS, electronic quality management systems, and technical writing experience.
- 5+ years’ working in a supervisory or management role
- Experience and/or expert knowledge with MDSAP regulations, ISO 13485 and EU MDR regulations.
- Extensive knowledge & experience implementing and managing:
- Quality Metrics and KPIs
- Internal Audit Program
- External Audit Management (FDA Inspections, Notified Body Audits, Customer Audits).
- Document Control and Quality Records
- Quality Management Review
- Ability to coach and mentor direct reports and lead a high-performing team.
- Ability to work independently with a high degree of initiative, attention to detail, and follow thorough.
- Excellent business communication skills, both written and verbal.
- Experience in coaching individuals through change to deliver improvements.
- Competency in MS Office, including Word, Outlook, Excel, and PowerPoint
- Strong desire to exceed expectations through difficult challenges, coupled with the ability to find solutions to problems.
- Driven self-starter, motivated by helping others to achieve deliverables.
- Ability to communicate effectively and build relationships at all levels.
- Capable of analyzing and utilizing data, without becoming lost in the detail.
- Ability to multi-task and prioritize work whilst handling rapidly changing priorities.
- Ability to travel as needed; up to 10% travel.
The Quality Systems Manager will have direct Supervision for all aspects of the quality systems/documentation control department. The Quality Systems Manager will manage subordinates within this department and is responsible for the direction, coordination, and their performance reviews.
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
MAIL A HARD COPY
c/o Apyx Medical Corporation
5115 Ulmerton Road
Clearwater, FL 33760-4004