Quality Manager

at  Steris

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.

PREFERRED EXPERIENCE

• Minimum of 8 years of experience with medical device, preferred
• ASQ, QSR or familiarity with QSR/GMP regulations preferred.
• Experience with statistical analysis software and Visio preferred.
• QMS system experience (such as Trackwise), preferred.

SKILLS

• 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.
• Experience with MS Office applications such as Excel, Word, and PowerPoint.

THE ROLE

The sourced product Quality Manager is responsible for leading quality improvement for segment of the business related to sourced product, including a manufacturing facility as well as procured product from third party suppliers. This position leads implementing and maintaining state-of-the-art quality practices for associated product lines. The Quality Manager assumes overall responsibility in ensuring that the site and suppliers maintain 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. This role leads the local site efforts and supplier quality functions 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 applicable site(s) and is responsible for ensuring the quality system meets all applicable regulatory standards.

WHAT YOU WILL DO

• Lead Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement, 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.
• Lead and implement effective production and process controls.
• Manage the complaint handling processes to insure customer responsiveness and product and process improvements.
• Ensure compliance to 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.

WHAT YOU WILL ALSO DO

• Determine supplier qualification risks based upon criticality of component and supplier process capability.
• The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management and regulatory compliance.
• This individual has autonomy to perform the duties of Person Responsible for Regulatory Compliance (PRRC) on behalf of STERIS legal manufacturing entities under the EU MDR. This individual shall suffer no disadvantage within the organization in relation to proper fulfilment of his or her duties in lieu of article 15 of the EU MDR.
• Perform other duties as assigned.
• 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