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Job Title:  Quality Systems Manager

Req ID:  26870
Job Category:  Quality

Pt. Richmond, CA, US, 94804

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

This Quality Manager is responsible for implementing and leading quality improvement initiatives for a state-of-the-art medical product manufacturing facility. This person assumes overall responsibility in leading and ensuring that the site maintains operational and quality systems compliance with domestic and international standards.  You will drive the organization, documentation and maintenance of the quality system to be compliant with the following standards: IS0 9001, ISO 13485, MDSAP and CFR Part 820/211, EU MDR. A person in 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. As a Leader and Management Representative for the site, you will be responsible for ensuring the quality system meets and exceeds all applicable regulatory standards while aligning with the corporate strategy. 

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. 
•    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. 
•    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.
 

Required Experience

•    8-12 years of Quality Engineering or Quality Systems experience preferably in an ISO-certified medical product environment
•    Minimum of 2 years in a Quality Leadership role in a regulated industry preferably in healthcare
•    The ability to fulfil the experience requirements listed in Article 15 of the EUMDR (PRRC) framework
•    ASQ, QSR or familiarity with QSR/GMP regulations strongly preferred
 

Skills

•    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 great systems and software experience, with advanced experience using a variety of reporting, analytics, and enterprise applications
•    Experience with statistical analysis software and Visio preferred
 

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 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.

Req ID:  26870
Job Category:  Quality

Pt. Richmond, CA, US, 94804


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland

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