Manager, Quality Systems

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.

Duties

• 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.

Education Degree

Bachelor's Degree in Engineering General

Required Experience

• 8-12 years of combined Manufacturing / Quality Engineering and / or Quality Systems experience.
• 8-12 years of experience with medical device or other regulated industries preferred.
• 8-12 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.

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Pay range for this opportunity is $91,250.00 - $127,575.00. This position is eligible for BONUS PARTICIPATION OR a INSERT COMMISSION RATE RANGE, IF APPLICABLE commission.

Minimum pay rates offered will comply with county / city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

Employees (and their families) may enroll in our company-sponsored medical, dental, vision, flexible spending, health savings account, voluntary benefits, supplemental life / AD&D plans and the company’s 401k plan.

Employees are covered by an employee assistance program (also available to household members) and long-term disability. Full-Time Employees are also eligible for short-term disability.

Full-time Employees will also receive Paid Time Off (PTO) based on years of service and paid Holidays. Part-time employees working 20 or more hours receive a pro-ration of the full-time PTO allocation and paid Holidays based on their standard hourly work week.

Full-Time employees are eligible for four weeks of paid parental leave. Part-time employees also receive paid parental leave, pro-rated based on their standard hourly work week.

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, life sciences and dental products and services.

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.

We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request.

The program may be obtained at your location’s HR Office during normal business hours.