Cantel Medical

Quality Engineer, Endoscopy Reprocessing/Electromechanical

US-MN-Plymouth
Job ID
2017-3660
# Positions
1
Category
Quality / Regulatory
Cantel ENDO

Company Overview

MEDIVATORS (formerly Minntech Corporation), a Cantel Medical Company, is a medical technology innovator of life-impacting solutions for over 35 years. Having a broad range of competencies in medical disposables, medical solution manufacturing, hollow fiber filtration, chemical disinfection, high level disinfection and sterilization,  the company serves the  healthcare, therapeutic, pharmaceutical, industrial and consumer markets. The company’s offerings improve healthcare and touch millions of lives in over 30 countries.

Job Overview

Provide quality engineering support to Manufacturing Operations by establishing and monitoring Key Process Indicators (KPI), leading problem solving to address quality-related issues and/or improving product quality, and investigating customer complaints. Utilize Cantel Endoscopy Correction and Preventive Action system to pursue continuous improvement of the Cantel Endoscopy Quality System and Cantel Endoscopy products. Assist with supplier support and play an active role in cost reduction projects supporting Lean initiatives. Partner with Manufacturing Engineering by navigating changes and supporting validations as they relate to product quality.

Main Responsibilities

  • Design and/or specify inspection and testing procedures/systems to ensure Cantel Endoscopy products conform to specifications and quality standards.
  • Investigate/analyze in-house and field failures (complaints), and improve product quality by determining root cause and recommending corrective action.
  • Propose, recommend, and oversee implementation of component and process improvements based on quality trends and prioritized through FMEA risk analysis.
  • Participate in investigation and analysis of customer complaints and field service trends.
  • Review and approve disposition for Nonconforming Product and lead Material Review Board (MRB).
  • Author, 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 Cantel Endoscopy Quality System and lead continuous improvement efforts of the Quality System.
  • Be key participant in CAPA Committee and any Data Review Committees.
  • Interface with personnel from all areas of the company to foster improved quality and efficiency.
  • Communicate quality metrics and project status to Focus Factory leadership.
  • Utilize QA Inspectors and Technicians as resources and key partners in Quality.

Qualifications

  • BS in Engineering (or equivalent) and a minimum of 2 years engineering work experience in the medical device industry, 4 plus years if experience is a non-life science industry.
  • Practical experience/familiarity with regulated environments, i.e. ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, ISO 14971 and other applicable standards.
  • Must possess practical knowledge related to products that the position will support, e.g., electromechanical product components and assembly processes.
  • Must have competent PC skills, and be highly proficient with Microsoft Word, Excel, and PowerPoint. Experience using Minitab statistical software is desirable.
  • Must have practical knowledge and experience in statistical analysis, problem-solving/process improvement techniques, and Root Cause Investigation/CAPA.
  • Familiar with the proper use of common inspection tools, test equipment, and visual standards.
  • Must be able to read and understand component/product specifications.

 

IDEAL CANDIDATE PROFILE:

Personal Characteristics:

  • Driven, self-starter, and passionate about Quality
  • Ability to manage multiple projects concurrently
  • Strong team building and cross-functional collaboration abilities
  • Excellent written and verbal communication skills
  • Strong organizational and time/project management skills
  • Adept with problem solving and process improvement data-driven methodologies
  • Keen attention to detail and critical-thinking

Minimum Qualifications

Cantel Medical 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.

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