Quality Manager

Quality Manager

The Quality Manager in our Chesterfield, MO Instrument Management Services (IMS) facility is responsible for leading quality improvement for our service facility. 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.

This position requires working onsite in our Chesterfield, MO location during core business hours 8 am to 5pm. Domestic travel up to 10- 20% based on business need, is required.

NOTE: To be considered for this role you must have a minimum of 8 years working in an ISO Certified (ISO 13485 strongly preferred) environment. Our locations are ISO Certified and in compliance with FDA regulations.

What You'll 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 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.
• Perform other duties as assigned.

The Experience, Skills and Abilities Needed

Required:

• Bachelor's degree in Engineering or related 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).
• Ability to travel 10 - 20% domestically, required.

Preferred:

• Minimum of 8 years of experience with medical device or other regulated industries preferred.
• Experience with ISO 13485, ISO 90001 or CFR Part 820/211 regulations, strongly preferred.
• ASQ, QSR Certification or familiarity with QMSR/GMP regulations preferred.

Other:

• 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, wellbeing, and financial future. Here is just a brief overview of what we offer:

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

Pay range for this opportunity is $107,525.00 - $139,150.00. This position is eligible for bonus participation.

STERIS offers a comprehensive and competitive benefits portfolio.

Open until position is filled.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity 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.