Sr Quality Assurance Engineer
Company: Cantel Medical
Posted on: May 3, 2021
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.
- 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
- 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
- Review and approve disposition
for Nonconforming Product and lead Material Review Board (MRB)
- 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
- 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
- Interface with personnel from
all areas of the company to foster improved quality and reduced
- 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.
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
- Must possess practical
knowledge related to products that the position will
- 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
- Must have practical knowledge
and experience in statistical analysis, SPC, and Design of
- Practical knowledge of EtO
Sterilization and process validation desirable.
- Must be able to properly use
most inspection tools and test equipment.
IDEAL CANDIDATE PROFILE:
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.
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
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.
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.
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
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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