Quality Systems Manager

The Quality Systems 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 Systems 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 Systems Manager serves as the Management Representative for the site(s) and is responsible for ensuring the quality system meets all applicable regulatory standards.

• 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, Lean efforts and drive quality improvement for products and services.
• Work closely with site senior management to provide 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 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. 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.

• Bachelor's Degree in Engineering or related technical field.
• 8-12 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience, required.
• 8-12 years of experience working in an ISO certified environment, required.
• Minimum of 2 years in a Quality leadership role, required.

• 8-12 years of experience with medical device or other regulated industries, preferred.
• Must fulfil the experience requirements listed in Article 15 of the EUMDR (PRRC), preferred.
• ASQ, QSR or familiarity with QSR/GMP regulations, preferred.

• This is an onsite schedule position based in Chesterfield, MO.
• The schedule is: M-F dayshift hours.
• Upto 20% travel expected.

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.

Here is just a brief overview of what we offer:

• Market Competitive Pay.
• Extensive Paid Time Off and 9 added Holidays.
• Excellent Healthcare, Dental, and Vision benefits.
• Long/Short Term Disability coverage.
• 401(k) with a company match.
• Maternity & Paternity Leave.
• Additional add-on benefits/discounts for programs such as Pet Insurance.
• Tuition Reimbursement and continued education programs.
• Excellent opportunities for advancement in a stable long-term career.

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