SUMMARY: The Quality Systems Engineer will serve as the Quality Subject Matter Expert to oversee and maintain processes within the Company’s Quality System including but not limited to Quality Agreements, CAPA, Internal Audits, External Audits (i.e. FDA, Customer Audits, Notified Body Audits), Document Control, Quality Records, Management Reviews, and Training Compliance & Effectiveness. Makes decisions based upon knowledge and experience, with regulatory compliance at the forefront of consideration and based on standards & regulations, change controls, corrective & preventive actions, and process improvement projects. 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.
Quality Systems: 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.
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.
Serve as the organization’s technical expert for the Company’s Quality Systems during internal and external audits.
Collaborate cross-functionally to update processes to be compliant with new regulations (MDSAP, EU MDR, ISO 13585, CE Mark) while meeting business needs.
Identify and support quality systems improvement initiatives.
Communicate issues related to the QMS to management as needed.
Provide mentoring and training for all associates on quality systems requirements.
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.
Internal & External Audits: Manage the audit program to ensure that all nonconformities raised against certification bodies during audits are effectively corrected and independently verified.
Perform regular audits of the Quality System Process to ensure system processes are operating in accordance with controlled procedures. Schedule and perform internal and on-site audit activities, to include pre-audit planning, audit execution and evaluation and post-audit follow-up and recommendations.
Review and audit new product development documentation to meet quality system requirements. 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).
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.
Corrective and Preventive Action (CAPA) system: Manage the CAPA system.
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.
Lead and document investigation, root cause analysis and corrective action plans for quality related issues such as corrective actions.
Responsible for project management and tracking of corrective action plan implementation. Support data collection and reporting on established quality metrics.
Oversee Management Review meetings and assist with gathering, preparing, analyzing, and presenting data to executive management on the performance of the Quality Management System.
Schedule and coordinate Management Review Meetings and follow-up to ensure that action items are completed. Review submissions to Quality Management System (QMS) for spelling, punctuation, formatting and assure appropriate review and approval.
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.
Develop, establish, monitor, and report on both corporate and departmental quality objectives, metrics, and goals.
Document Control: Manage the document control process.
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.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.
SUPERVISORY RESPONSIBILITIES: This position does not have any direct reports or supervisor responsibilities.
Education and Experience
Minimum Bachelor (BS) degree in Engineering or relevant Technical degree from a 4 year college; at least 5-10 years related proven experience implementing and Managing:
Metrics, CAPA, Internal Audit Systems, Quality Agreements, FDA Inspections, Notified Body audits, Internal audits.
ISO 13485:2016, Lead Auditor Certification, JPAL, 21 CFR Part 820, MDSAP, MDD 93/42 / EEC, ISO 14971.
Expert knowledge of EU MDR (Medical Device Regulations).
Internal quality auditor or lead auditor certification in a regulated environment.
Extensive knowledge & experience of working with Lean / 6 Sigma continuous improvement and problem-solving tools and techniques.
Previous experience participating in continuous improvement activities.
Black Belt Certification preferred.
Excellent written and verbal communications skills. Demonstrates interpersonal and self-management skills. Strong organizational skills and attention to detail. Experience with Microsoft Office applications including Excel, Word, Power Point and Outlook.
Courage: Not afraid to stand up for his/her beliefs or voice an unpopular opinion. Is looked at for direction in a crisis. Willing to try new ways without fear of failure. Challenges the status quo. Takes stands to resolve important issues. Energized by tough challenges. Is comfortable with change.
Analyzing & Problem Solving Skills: Use an analytical approach; evaluate a situation from varying perspectives to create well-reasoned solutions. Uses rigor and logic to solve difficult problems, provides honest analysis and looks beyond the obvious. Is able to offer options with a clear evaluation of the risk. Demonstrates continuous learning and looks for opportunities to create process improvements.
Organizational Agility: Able to foster excellent relationships and credibility quickly at all levels of the organization. An ability to create a partnership atmosphere with internal and external resources while achieving key operating objectives. Can see and understand what drives policies, practices, and procedures.
Customer & Patient Focus: This individual needs to understand company's customers and competition to maximize opportunities and advantages, and search for ways to leverage the company's current position. Advocates for patient safety and health above all else.
Results Focused: A confident individual who provides a good balance of risk taking and sound judgment in order to deliver optimal results. Is able to drive goal attainment in others with energy and focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Minimum Bachelor (BS) degree in Engineering or relevant Technical degree from a 4 year college; at least 5-10 years related proven experience
Internal Number: QSE
About Bovie Medical Corporation
Bovie Medical Corporation is a leading maker of medical devices and supplies as well as the developer of J-Plasma® (marketed and sold under the Renuvion™ Cosmetic Technology brand in the cosmetic surgery market), a patented plasma-based surgical product for cutting, coagulation and ablation of soft tissue. J-Plasma/Renuvion technology utilizes a helium ionization process to produce a stable, focused beam of plasma that provides surgeons with greater precision, and minimal invasiveness. The new J-Plasma/Renuvion handpieces with Cool-Coag™ technology deliver the precision of helium plasma energy, the power of traditional monopolar coagulation and the efficiency of plasma beam coagulation - enabling thin-layer ablation and dissection and fast coagulation with a single instrument, minimizing instrument exchange and allowing a surgeon to focus on their patient and their procedures. With Cool-Coag technology, the new J-Plasma/Renuvion handpieces can deliver three distinctly different energy modalities - further increasing the utility and versatility of the system. Bovie Medical Corporation is also a leader in the manufacture of a range of electrosurgical products and technologies, marke...ted through both private labels and the Company’s own well-respected brands (Bovie®, IDS™ and DERM™) to distributors worldwide. The Company also leverages its expertise through original equipment manufacturing (OEM) agreements with other medical device manufacturers. For further information about the Company and its products, please refer to the Bovie Medical Corporation website at www.boviemedical.com.