Cantel Medical Senior Quality Engineer in Conroe, Texas
Redefining Excellence In:
Medical Device Reprocessing. Endoscopy Procedure Products and Infection Prevention and Control
We are a leader in the design, development, manufacture and sale of medical devices critical to endoscopy and infection prevention and control. Our Endoscopy segment provides a full circle of infection prevention solutions through a comprehensive offering of MEDIVATORS® branded products and services in two critical areas – endoscope reprocessing and endoscopy procedure products. Our endoscope reprocessing products include a full range of endoscope reprocessing systems, high-level disinfectants and sterilants, detergents, leak testing and manual cleaning products, storage cabinets, endoscope process tracking and related consumables, accessories and supplies.
Our endoscopy procedure products include CO2 and water irrigation pumps and disposable procedure kits, sterile irrigation tubing and single-use valves designed to eliminate the challenges associated with proper cleaning and high-level disinfection of numerous reusable components used in GI endoscopy procedures. We design, develop and manufacture most of our endoscopy products.
Provide quality engineering support to Manufacturing Operations and R&D by resolving quality-related injection molding issues, improving product quality, and reducing costs. Utilize the Medivators Correction and Preventive Action system to pursue continuous improvement of the Medivators Quality System and products. Assist with supplier support and play an active role in cost reduction projects that support Lean initiatives. Represent Quality Assurance on Research and Development project teams. Support Manufacturing Engineering by reviewing validations of molded components as they relate to product quality.
• BS in Engineering (or equivalent) and a minimum of 7-10 years' experience in Engineering required.
• Experience with ISO 9001 or 13485 required. Additional experience with FDA Quality System Regulations, ISO 14971, or other applicable standards a plus.
• Must possess practical knowledge related to molded products and molding processes.
- Previous experience in Injection Molding facility highly desired
• Possess basic PC skills, and have working knowledge of Microsoft Word, Excel, and Access. Experience with Minitab preferred.
• Have practical knowledge and experience in statistical analysis, SPC, and Design of Experiments.
• Must be able to properly use most inspection tools and test equipment.
• Must be able to read and understand component/product specifications.
• Design and/or specify inspection and testing procedures/systems for injection molded products to ensure Medivators products conform to specifications and quality standards.
• Investigate/analyze in-house and field failures (returns) and monitor quality trends. Propose and implement possible solutions/improvements utilizing the Medivators Corrective and Preventive Action (CAPA) system.
• Participate in review of injection molding processes to assure validations are current and acceptable.
• Participate in development of validation plans for new molding machines and molded components, including scientific molding.
• Review and approve disposition for Nonconforming Product and participate in Material Review Board (MRB) team.
• Review and approve Engineering Change Orders (ECO), Deviation Authorizations, Qualification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures.
• Lead efforts to continuously improve molded product quality, while ensuring safety, efficacy and regulatory compliance.
• Support all functional departments to ensure compliance with Medivators’s Quality System and lead continuous improvement efforts of the Quality System.
• Represent Quality Assurance on product development teams, including developing Quality Plans and Risk Management Plans.
• Be key participant in CAPA Committee and Data Review Committee.
• Interface with personnel from all areas of the company to foster improved quality and reduced cost.
• Lead or be key participant in preparation/evaluation of pFMEAs.
Medivators, a Cantel Medical company is an Equal Employment Opportunity/Affirmative Employer. Women, minorities, veterans, and individuals with disabilities as well as other qualified individuals are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin or other protected class status.