SUMMARY: The Quality Systems Manager assumes responsibility for management and technical leadership for the development and management of Bovie Medical Corporation quality systems, including but not limited to Quality Agreements, CAPA, non-conforming materials, internal audits, 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: Other duties may be assigned from time to time.
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 audit program to ensure that all nonconformities raised against 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.
Manage interactions with internal and external customers concerning the quality of products, systems, and processes.
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.
Partner 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.
Partner 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 and issue reports to ensure Bovie Medical’s leadership is informed of the Quality Systems performance and Bovie 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.
Develop, establish, monitor, and report on both corporate and departmental quality objectives, metrics, and goals.
Promote and ensure companywide quality system compliance with all applicable national and international standards and regulations.
Embed a culture of continuous improvement throughout the company. Lead the team to achieve quality management system targets for customers and business goals.
QUALITY ASSURANCE RESPONSIBILITIES: The Quality Systems Manager must comply with the following quality system requirements including but not limited to:
Use only formally approved procedures, records, documents and specifications known as “Control Documents” (e.g., device history records, data collection forms, drawings, procedures, and specifications).
Use only properly calibrated and maintained equipment.
Immediately bring to the attention of the he Quality Assurance Director any possible deviations from specified Standard Operating Procedures or Work Instructions he or she may notice.
Follow all Standard Operating Procedures and Work Instructions relating to the functions preformed.
SUPERVISORY RESPONSIBILITIES: The Quality Systems Manager will have direct Supervision for all aspects of the documentation control department. The QA Systems Manager will manage two subordinates and is responsible for the direction, coordination and their performance reviews
Metrics, CAPA, Internal Audit Systems, Quality Agreements, FDA Inspections, Notify Body audits, Internal.
ISO 13485:2016 Lead Auditor Certification, JPAL, 21 CFR Part 820, MDSAP, MDD 93/42 / EEC
Managing direct reports
EDUCATION AND EXPERIENCE: A Bachelor’s Degree (BA or BS) from a four-year College or University, and five to ten years of related proven experience implementing and Managing;
QUALIFICATIONS: 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.
Internal Number: QS1
About Bovie Medical Corporation
Bovie Medical Corp. is a leading maker of medical devices and supplies as well as the developer of J-Plasma®, a patented plasma-based surgical product. J-Plasma® utilizes a gas ionization process that produces a stable, focused beam of ionized gas that provides surgeons with greater precision, minimal invasiveness and an absence of conductive currents through the patient during surgery. J-Plasma®, still in the early stages of commercialization, has the potential to be a transformational product for surgeons.
Bovie Medical is also a leader in the manufacture of a range of electrosurgical products and technologies. These are marketed through both private labels and Bovie’s own well-respected brands (Bovie®, Aaron®, IDS™ and ICON™) to distributors worldwide. The Company also leverages its expertise through original equipment manufacturing (OEM) agreements with other medical device manufacturers.