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Job Title:  Senior Supplier Quality Engineer

Req ID:  27873
Job Category:  Quality

Plymouth, MN, US, 55447

Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

Provide supplier quality engineering support to Manufacturing Operations by establishing and monitoring Key Process Indicators (KPI), leading problem solving to address supplier quality-related issues, improving component quality, and supporting customer complaint investigations related to supplied components.  Utilize Cantel Corrective and Preventive Action system to pursue continuous improvement of the Cantel Quality System and Cantel products.  Play an active role in cost reduction projects supporting Lean initiatives. Partner with Supply Chain, Manufacturing and Product Engineering teams by navigating changes, supporting validations, and leading component qualification and inspection plans as they relate to product quality.

Duties

  • Effectively partners with suppliers to ensure Cantel products conform to specifications and quality standards while driving continuous improvement with vendors.
  • Implement FMEA/risk-based incoming inspection processes and lead quality at the source initiatives.
  • Systematically monitor risk in the supply chain through the vendor approval process, onsite assessments, and supplier metrics.
  • Communicate quality issues to suppliers and the value stream through proactive relationships.
  • Evaluate proposed changes at suppliers and support change management.
  • Design and/or specify inspection and testing procedures/systems
  • Lead the supplier corrective action process (SCAR) and investigate/analyze in-house and field failures (complaints), and improve product quality by determining root cause and recommending corrective actions.
  • Propose, recommend, and oversee implementation of the component and process improvements based on quality trends.
  • Participate in the investigation and analysis of customer complaints and field service trends.

Duties - cont'd

  • Review and approve disposition for Nonconforming Product and support 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 related to supplied components.
  • Lead efforts to continuously improve product quality while ensuring safety, efficacy and regulatory compliance.
  • Support all functional departments to ensure compliance with Cantel Quality System and lead continuous improvement efforts of the Quality System.
  • Be a key participant in CAPA Committee and any Data Review Committees.
  • Closely partner with Purchasing/Planning commodity teams and interface with personnel from all areas of the company to foster improved quality and efficiency.
  • Communicate supplier quality metrics and project status to Focus Factory leadership.
  • Utilize QA Inspectors and Technicians as resources and key partners in Quality.

Education Degree

Bachelor's Degree

Required Experience

  • BS in Engineering (or equivalent) and a minimum of 5 years quality engineering work experience in the medical device industry, 8 plus years if the experience is a non-life science industry.
  • Experience/familiarity with regulated product quality system requirements, i.e. ISO 13485, FDA Quality System Regulations, ISO 14971, and other applicable standards.
  • Relevant experience with supplier quality systems and processes including Supplier Corrective Actions (SCAR), Production Part Approval (PPAP), First Article Inspection (FAI), Supplier Quality Agreements, Supplier Audits, Supplier Transitions, and Product Change Notifications.

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Req ID:  27873
Job Category:  Quality

Plymouth, MN, US, 55447


Nearest Major Market: Minneapolis

Job Segment: Senior Quality Engineer, Quality Engineer, Medical Device Engineer, Manufacturing Engineer, Supply Chain, Engineering, Operations