SUMMARY: The Quality Engineer-Sustaining provides quality support for the Business to ensure that the quality of the raw materials used and products manufactured meet customer expectations. Responsible for ensuring that documented practices meet the true interpretation of the quality management system standards by overseeing the testing, monitoring, and inspecting processes of the Business. Responsible for providing engineering support to operations to ensure consistent application of quality techniques, determining quality improvement parameters, monitoring production quality, determining the need for process validations, the ETO & Gamma sterilization validation program, investigation of manufacturing issues & supplier non-conformances, and developing test procedures in support of the Business.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
Provide engineering support to operations ensuring consistent application of quality techniques:
Resolve quality issues of capability, tolerances, and materials related issues.
Resolve quality issues by identifying problems, examining solution options, implementing action plans, and providing resources.
Regularly monitor the production process to ensure quality.
Responsible for the formulation of the testing procedures for quality checking.
Collect the relevant data from the various related sources and analyze to effectively monitor and ensure quality outputs.
Quickly and effectively take action when non-conformances are found.
Support Lean and Kaizen events to improve manufacturing and QA process flow and assembly processes for QC and Mfg.
Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
Establish statistical confidence by identifying sample size and acceptable error and determining levels of confidence; maintain statistical process controls and develop sampling plans.
Establish statistical reliability by using statistical methods.
Develop test procedures and test proposed components for product improvements/substitution.
Analyze data by completing hypothesis, normal distribution, and process capability analysis tests.
Prepare reports by collecting, analyzing, and summarizing data; making recommendations.
Monitor production to assure processes are being followed.
Provide inputs on inspection methods & improvements.
Ensure performance and product quality conforms to established company and regulatory standards.
Promote and assist in development of SPC plans to ensure processes are in-control.
Analyze data for process improvement & corrective actions.
Develop metrics to monitor trends and present data to facilitate quality, risk-based decision making.
Provide quality reports to management daily, weekly and monthly for review of process capability.
Ensure inspections are performed per the Quality Plan.
Lead and/or participate in quality process improvement projects.
Participate in process and product validations.
Work with cross functional teams to support continuous improvement projects.
Determine the need for validation activities identified through investigations and process improvements. Analyze/evaluate validation data and draw conclusions based on evaluation Review and provide quality input to validation protocols and reports.
Responsible for the ETO and GAMMA Sterilization process; Provide expert knowledge on sterilization process validation.
Communicate with Supplier Quality Program to promote the resolution of supplier related issues impacting production; Investigate manufacturing, systems & supplier non-conformances through the Corrective and Preventative Action process, determine root cause of non-conformances, and recommend changes or corrections.
Responsible for oversight of Environmental monitoring (Particulates, Temp & R/H) and bioburden monitoring, for reporting trends and escalate issues to management.
Oversight of the Calibration program to ensure compliance.
Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
Other duties may be assigned from time to time.
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.
EDUCATION AND EXPERIENCE: A Bachelor’s Degree (BA) from a four-year College or University, and applied experience/knowledge in Design Control, Process Validation, FMEA/Risk Assessment, and ISO/QSR and 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, 8D, PDCA
Expert knowledge of 21 CFR Part 820, ISO 13485:2016, MDSAP, MDD 93/42 /EEC
Experience with applying mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis or variance, correlation techniques, sampling theory, and factor analysis.
Internal Number: SQE
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.