STERIS Canada Corporation
Quality Systems Manager
STERIS Canada Corporation, Mentor, Ohio, United States, 44060
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 a manufacturing or service facility/function. This position leads implementing and maintaining state-of-the-art quality practices for associated product and service lines. The Quality Manager assumes 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. This role 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.What you will do as a Quality Manager
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 ensure 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.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.Experience, skills, and abilities needed
Bachelor’s degree (Engineering or related technical field)Minimum 8 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.Minimum 8 years of experience with medical device or other regulated industries preferred.Minimum 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).ASQ, QSR or familiarity with QSR/GMP regulations preferred.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.Experience with statistical analysis software and Visio preferred.What STERIS offers
We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.Here is a brief overview of what we offer:Market competitive payExtensive paid time off and (9 added holidays)Excellent healthcare, dental, and vision benefitsLong/short term disability coverage401K with company matchMaternity and parental leaveAdditional add on benefits/discounts for programs such as pet insuranceTuition reimbursement and continued educational programsExcellent opportunities for advancement in a stable long-term careerSTERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.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.
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The Quality Manager is responsible for leading quality improvement for a manufacturing or service facility/function. This position leads implementing and maintaining state-of-the-art quality practices for associated product and service lines. The Quality Manager assumes 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. This role 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.What you will do as a Quality Manager
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 ensure 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.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.Experience, skills, and abilities needed
Bachelor’s degree (Engineering or related technical field)Minimum 8 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.Minimum 8 years of experience with medical device or other regulated industries preferred.Minimum 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).ASQ, QSR or familiarity with QSR/GMP regulations preferred.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.Experience with statistical analysis software and Visio preferred.What STERIS offers
We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.Here is a brief overview of what we offer:Market competitive payExtensive paid time off and (9 added holidays)Excellent healthcare, dental, and vision benefitsLong/short term disability coverage401K with company matchMaternity and parental leaveAdditional add on benefits/discounts for programs such as pet insuranceTuition reimbursement and continued educational programsExcellent opportunities for advancement in a stable long-term careerSTERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.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.
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