Quality Manager

STERIS•Saint Louis, MO

21d•Onsite

About The Position

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 The Quality Manager is responsible for leading quality improvement for in our St. Louis, Missouri manufacturing facility. In this role you will implement and maintain state-of-the-art quality practices for associated product and service lines. You will assume overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards. The role is responsible for the organization, documentation and maintenance of the quality system to be compliant with, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and CFR Part 820/211, EU MDR and other applicable standards. The Quality Manager leads the local site efforts focused on product/service quality improvement, supplier quality, process quality, new product/service development quality and quality system compliance. The Quality Manager serves as the Management Representative for the site(s) and is responsible for ensuring the quality system meets all applicable regulatory standards. This position requires working onsite in our St. Louis, Missouri facility.

Requirements

Bachelor’s degree in Engineering or related technical field.
Minimum of 8 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
Minimum of 8 years of experience working in an ISO certified environment required.
Minimum of 2 years in a Quality leadership role.
Must fulfil the experience requirements listed in Article 15 of the EUMDR (PRRC)
Excellent problem-solving skills
Focus on identification of potential issues and continuous improvement.
Experience working on cross-functional teams and on own initiative.
Demonstrated excellent organizational, oral and written communications skills.
Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.

Nice To Haves

Minimum of 8 years of experience with medical device or other regulated industries, preferred.
ASQ, QSR Certification or familiarity with QSR/GMP regulations, preferred.
Experience with statistical analysis software and Visio, preferred.

Responsibilities

Lead the organization’s Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement.
Lead the organization’s Quality staff to ensure alignment to manufacturing and servicing operations, support Lean efforts and drive quality improvement for products and services.
Work closely with site senior management to provide strategic direction and development of the organization’s quality strategies and tactics.
Provide quality viewpoints and opinions on future product and service development.
Provide coaching, mentoring and leadership to the Quality staff.
Serve as the site’s Management Representative and lead the organization’s Management Review process.
Ensure compliance with appropriate domestic regulatory and international standards and requirements.
Lead the organization's continuous improvement process, including data analysis, improvement projects and process capability to improve key metrics as measured by the product/service quality dashboard.
Lead and implement effective production and process controls.
Manage the complaint handling processes to insure customer responsiveness and product and process improvements.
Ensure compliance with the New Product Development process and assurance that the Product Requirements Document includes key quality performance metrics.
Assess new designs for manufacturability, testability and reliability to ensure the Quality risks and deliverables of the New Product Development process meet the required application reliability and design intent.
Determine supplier qualification risks based upon criticality of component and supplier process capability.
Perform other duties as assigned.