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Sr Quality Assurance Engineer

Company: Cantel Medical
Location: Conroe
Posted on: May 3, 2021

Job Description:

Provide quality engineering support to Manufacturing Operations by resolving quality related issues, improving product quality, investigating customer complaints and reducing cost. Utilize the Correction and Preventive Action system to pursue continuous improvement of the 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 to complete validations and conduct validations as it relates to quality of products.  #CB

  • 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 Corrective and Preventive Action (CAPA) system.
  • Participate in investigation and analysis of customer complaints or direct Quality Engineers and Quality Engineering Technicians to help with investigation and testing
  • Review and approve disposition for Nonconforming Product and lead Material Review Board (MRB) teams.
  • Initiate supplier corrective actions and assist Purchasing to continuously improve supplier quality and enhance supplier relationships.
  • 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 product quality, while ensuring safety, efficacy and regulatory compliance.
  • Support all functional departments to ensure compliance with the Quality System and lead continuous improvement efforts of the Quality System.
  • Facilitate customer audits and assist as needed with external audits such as FDA and ISO.
  • Interface with personnel from all areas of the company to foster improved quality and reduced cost.
  • Supervise QA Inspectors and QA Technicians as defined by Quality Leadership

  • BS in Engineering (or equivalent) and a minimum of 5 years engineering work experience. Prefer that the work experience is in the medical device industry as a Quality Assurance Engineer.
  • Practical experience/familiarity with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Laboratory Practices, ISO 14971 and other applicable standards.
  • Must be highly organized and have the ability to manage multiple projects concurrently.
  • Must possess practical knowledge related to products that the position will support.
  • Must possess good written and verbal communication skills as well as team building skills, basic PC skills, and have working knowledge of Microsoft Word, Excel, and Access.
  • Must have practical knowledge and experience in statistical analysis, SPC, and Design of Experiments.
  • Practical knowledge of EtO Sterilization and process validation desirable.
  • Must be able to properly use most inspection tools and test equipment.



Leadership Attributes

Has the confidence, presence and ability to inspire, influence, motivate and empower people. Listens to and values feedback; supports and explains reasoning for decisions. Is an effective mentor and coach to team members. Respectful of, and actively solicits, team member opinions.


Personal Characteristics
Strong written and oral skills, together with strong organizational skills are a must.

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.


Keywords: Cantel Medical, Conroe , Sr Quality Assurance Engineer, Other , Conroe, Texas

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