Post Market Quality Engineer

Who we are

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

The Post-Market Quality Engineer supports Cantel Medical's Sustaining Engineering teams and plays a key role in post-market projects. The Post-Market Quality Engineer is responsible forengineering activities including review and gap assessment of design requirements, development, execution and maintenance of risk management plans and activities, identification of applicable standards, review of component and system level specifications, test method development, test plan and protocol development for Design Verification and Design Validation activities, data review and analysis from key testing activities, participating in Design Stage Reviews and process validation activities related to Design Transfer to Manufacturing. #CB

What you will do

• Work with Cantel Medical sustaining Engineering team to execute risk-based approach/procedure/plan to design requirements/specifications, technical standards, test methods, test plans, test protocols and test data analysis.
• Responsible for partnering with Sustaining teams and Supply Chain personnel in the assessment of component and system level specifications relative to customer needs and product performance specifications.
• Apply Design for Reliability and Manufacturability tools and techniques to ensure Cantel product designs are robust, fit Cantel's manufacturability model, and meet customer needs.
• Provide effective Quality Engineering support for multiple projects, balancing priorities and resources appropriately to meet both project and management expectations.
• Collaborate with R&D, Marketing, Regulatory Affairs, Supply Chain and Manufacturing to ensure effective and robust risk management, testing, verification, validation, IQ/OQ/PQ asapplicable for products and processes in the concept to market phases of product development.
• Assist in continuous improvement activities as necessary and as driven by product lifecycle management that generate Sustaining Engineering projects.
• Prepare oral and/or written reports of analysis for Design Verification, Design Validation and other critical testing and evaluation activities, as required by the project or department management.
• Update job knowledge by keeping up to date on trends and developments in quality assurance, statistical analysis, test development, ISO 13485, MDD, TGA, Health Canada and FDA quality systems, and participating in educational opportunities.

What we are looking for

• BS degree required, Diploma holder in Engineering or Physics
• 3 plus years Design Quality Assurance experience in a regulated medical device environment, specifically in a product development support role
• Experience in responsibility for compliance to FDA, MDR and ISO regulations
• Experience in responsibility for medical device Design Verification and Validation activities
• Experience in and responsibility for product and process risk analysis/FMEA, specification writing, test method development, statistical analysis of quantitative and qualitative data, test report writing and medical device design reviews.
• Previous work experience in life science products or medical device fields is required
• Proficient in computer skills such as MS office programs

IDEAL CANDIDATE PROFILE:
Personal Characteristics:

• Strong written and oral skills
• Strong organizational and management skills
• Strong problem-solving skills
• Strong attention to detail