Principal Quality Assurance Engineer
Company: Cantel Medical
Posted on: February 22, 2021
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
- Design and/or specify inspection and testing procedures/systems
to ensure products conform to specifications and quality
- 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
- 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
- Lead coordinated efforts to continuously improve product
quality, while ensuring safety, efficacy and regulatory
- 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
- 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
- BS in Engineering and a minimum of 7 years' experience in
- 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
- 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
- Prefer that the work experience is in the medical device
industry as a Quality Assurance Engineer. Sorry the Share function
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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
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
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