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Quality Systems Supervisor

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 position is responsible for developing, maintaining and improving the Quality Management System in accordance with the requirements of, as appropriate, the following standards (AAMI; ISO 9001; ISO 13485; MDSAP; FDA 21 CFR Part 820). This would include but is not limited to: reduction of non-compliance, complaint handling, supplier quality management, in-process controls, and corrective actions through the use of statistical techniques and other accepted Quality principles.This position plans and executes activities concerned with development, implementation, maintenance, and continuous improvement of our Quality Management System.
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Duties
Lead/participate on cross-functional improvement teams with focus on product quality and Quality Management System compliance.
Initiate/participate/lead Customer complaint, corrective action and problem-solving activities.
Update/establish documented work instructions as needed.
Review collected data, perform statistical analysis and recommend process / product changes to improve product and process quality.
Monitor and report on Quality performance metrics.
Train and develop other STERIS employees on quality principles, effective corrective actions, and valid statistical techniques.
Collaborate with other departments and facilities within the company on quality and compliance related issues, and Lean/Continuous Improvement initiatives.
Perform internal and external Quality Management System audits and provide guidance on corrective actions.
Work with suppliers to improve component or service quality.
Perform all other duties as assigned.
Duties - cont'd
Education Degree
Bachelor's Degree
Required Experience
3+ years of Quality Management Systems experience
3+ years of experience in a fast-moving manufacturing or service environment
3+ years of experience in healthcare, medical device or other regulated industry preferred
3+ years of experience working within a regulated or certified Quality Management System required
ASQ, QSR, or AAMI certification preferred.
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, PowerPoint.
Experience with statistical analysis software and Visio preferred.
Experience in equipment validation methods desirable.
STERIS is a $2B+, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates 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.
Req ID: 13464
Category: Clinical Support, Operations & Education
City: Bethpage
State: NY
Postal Code: 11714
Nearest Major Market: Long Island
Nearest Secondary Market: New York CIty
Job Segment: Manager, Medical, Quality Manager, Medical Device, Quality, Management, Healthcare


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