Principal Quality Assurance Engineer

Company: Cantel Medical
Location: Plymouth
Posted on: February 22, 2021

Job Description:

All trademark and product names are trademarks of Cantel Medical Corp., its affiliates and related companies. OLYMPUS--, PENTAX--, FUJIFILM---, STORZ--, and WOLF-- are trademarks of their respective owners. At Cantel, preventing infection is our business. As a leading provider of infection prevention products and services in the healthcare market, we are dedicated to delivering high-quality, innovative solutions that improve outcomes and help save lives. We accomplish this mission by delivering our products through the following operating units: Medical : Endoscopy procedure disposables include single-use valves and irrigation tubing. The medical device reprocessing systems, disinfectants, detergents we manufacture and distribute are used to disinfect high-level endoscopes. Life Sciences : Water purification systems for dialysis facilities. We work with leading dialysis caregivers, delivering hemodialysis dialyzers and reprocessing systems, as well as sterilants and filtration products. Dental: Single-use, infection prevention products used primarily in the dental market (face masks, sterilization pouches, towels and bibs, tray covers, saliva ejectors, germicidal wipes, plastic cups and disinfectants).-- Cantel employees are inspired to improve the lives of patients, caregivers and healthcare providers. If you are looking for a company driven by an entrepreneurial spirit and have the passion to shape the future of infection prevention, we want to meet you. Join us and see why people love working here. About the role Provide technical quality engineering leadership, oversight and management in support of Manufacturing Operations and R&D. Responsible for proactively identifying quality-related issues, improving product quality, investigating customer complaints and reducing costs. Provide technical leadership in the continuous improvement of the Quality System and products through the Correction And Preventive Action (CAPA) system. Responsible to ensure supplier support and manage cost reduction projects that support Lean initiatives. Be the technical Quality Assurance expert on Research and Development project teams. Ensure support for Manufacturing Engineering by providing guidance and support of validations as they relate to product quality. #CB What you will do

• Provide technical direction and lead quality engineering activities to drive resolution of qua lity-related issues, improving product quality, investigating customer complaints and reducing costs.
• Design and/or specify inspection and testing procedures/systems to ensure 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 CAPA system.
• Lead investigation and analysis of customer complaints as requested by Quality Engineer and Quality Engineering Technician.
• 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 coordinated efforts to continuously improve product quality, while ensuring safety, efficacy and regulatory compliance.
• Provide subject matter expertise and technical leadership with all functional departments to ensure compliance with 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 technical leader in CAPA Committee and any Data Review Committees.
• Interface with personnel from all areas of the company to foster improved quality and reduced cost.
• When applicable, supervise Quality Assurance of QA Inspectors and QA Technicians as defined by QA leadership What we are looking for
  • BS in Engineering and a minimum of 7 years' experience in Engineering required
  • Demonstrated in-depth experience/familiarity with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, ISO 14971 and other applicable standards.
  • Must possess demonstrated knowledge related to products that the position will support.
  • Possess strong PC skills, and have working knowledge of Microsoft Word, Excel, and Access.
  • Must have strong knowledge and experience in statistical analysis, SPC, and Design of Experiments.
  • Must be able to understand and properly use inspection tools and test equipment.
  • Must be able to read and understand component/product specifications.
  • Must be highly organized and have the ability to manage multiple projects concurrently.
  • Must possess good written and verbal communication skills
  • Must demonstrate strong ability to work well with cross-functional teams and posess team building skills. PREFERRED QUALIFICATIONS:
    • Prefer that the work experience is in the medical device industry as a Quality Assurance Engineer. Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Loading...
      
      Cantel 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.
      
      Cantel maintains a drug-free workplace. Cantel is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Keywords: Cantel Medical, Plymouth , Principal Quality Assurance Engineer, Engineering , Plymouth, Massachusetts