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Job Title:  Quality Specialist

Req ID:  16151
Job Category:  Quality
Country:  US
State:  MO
City:  St. Louis
Zip:  63133
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.

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The Quality Systems Specialist is responsible for all aspects of customer product complaint handling, including tracking, coordinating investigation, trending and reporting as required and providing response to customer as required.  This position also assists in maintenance and implementation of quality systems to assure compliance with FDA cGMP and other quality standards, with prime responsibilities to include oversight of non-conformances and CAPA, failure investigations, tracking and trending of quality data for QRB and QMR.  The QS Specialist also maintains quality system procedures, conducts internal and external audits and supports Lean initiatives as required.

Position Summary

Duties

1.    Implement and maintain Complaint procedures to comply with FDA GMP and QSR regulations and ISO requirements.

2.    Coordinate Complaint investigations and corrective actions for consumables produced through the St. Louis quality system.  Assure adequate root cause analysis, risk analysis and complete complaint investigation reports.  Provide response to customer as required.  Log and track all complaints to assure timely completion.

3.    Analyze and trend complaint data and provide reports for management review at periodic intervals.

4.    Oversee tracking, investigation and effective close-out of Non-Conformances, Failure Investigations and Deviations, providing trending and reports for Quality Review Board and Management Review.  Provide support to risk analysis.

5.    Conduct internal company audits for FDA cGMP, QSR and ISO compliance including reporting and tracking of the audits.

6.    Conduct external supplier audits as required and review of returned supplier questionnaires.

7.    Host customer audits, tracking and close-out of audit findings.  Complete customer questionnaires as required.

8.    Maintain current SOPs for operations functions.  Assist with SOP management support to Product Development, Regulatory Affairs and Life Sciences.

       9.    Perform other quality system duties as required to support FDA cGMP compliance such as Annual Product Review and other quality projects and manufacturing site initiatives.

Education Degree

  • Bachelor's Degree

Required Experience

Specific work experience requirements:

1-3 years experience in Quality or related field preferably in chemical or medical device industry along with a strong knowledge of the FDA Drug and Medical Devise regulations.  Quality Systems certifications preferred.  Excellent written and verbal communication skills required.

Specific skills and/or business competencies:

Extensive use of phones and computers, with knowledge of software such as Excel, Word and PowerPoint.  Office environment.  Some manufacturing plant work and approximately 15% travel.

 

 

 

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.

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.


Nearest Major Market: St Louis

Job Segment: Medical, Product Development, CAPA, Inspector, Quality, Healthcare, Research, Management