Job Description

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 an AST processing or lab facility. This position leads implementing and maintaining state-of-the-art quality practices and 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: ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. This role leads the local site efforts focused on quality system improvement, supplier quality, process quality, new service/modality/technology 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. 

The Quality Manager has the responsibility, duty, and decision-making authority to put any product on hold that is identified as potentially non-conforming and escalating as needed for additional reviews by technical teams.

What you’ll do as the Manager of Quality Systems

• 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 operations, support Lean efforts and drive quality improvement for services/processes.
• 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 service/technology offerings.
• 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 CAPA, complaint and non-conformance handling processes to insure customer responsiveness and process improvements. 
• Responsible for successfully leading and managing Regulatory Agency and Notified Body inspections and driving the creation and implementation of sustainable and effective remediation plans. Responsible for overseeing completion of Customer audits. 
• Apply regulatory knowledge and judgment to the evaluation of quality concerns and regulatory compliance issues. 
• Travel to other AST facilities, domestically and/or globally, to support remediation activities, audits/inspections, and/or continuous improvement initiatives. 
• Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards, and regulations. 
• The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management, and regulatory compliance. 
• Perform other duties as assigned.
  

The Experience, Skills, and Abilities needed

Required:

• Bachelor’s Degree (Engineering or related technical field).
• Minimum 10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Minimum 10 years of experience working in an ISO certified environment required.
• Minimum of 2 years in a Quality leadership role. 

Preferred:

• Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
• Minimum 10 years of experience with medical device or other regulated industries 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.
• Effective interpersonal skills, ability to work independently under minimal guidelines and supervision.
• 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.
• Ability to work in a fast-paced, regulated environment with strict deadlines and ever-changing responsibilities.
• Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra. 

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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 pay
• Extensive paid time off and (9) added holidays
• Excellent healthcare, dental, and vision benefits 
• Long/short term disability coverage
• 401(K) with company match 
• Maternity and parental leave 
• Additional add on benefits/discounts for programs such as pet insurance 
• Tuition reimbursement and continued educational programs
• Excellent opportunities for advancement in a stable long-term career 

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.

If you need assistance completing the application process, please call 1 (440) 392.7047 . This contact information is for accommodation inquiries only and cannot be used to check application status.

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.

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