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Title:  Manager, Quality Systems

Req ID:  11484
Category:  Quality
City:  Mentor
State:  OH
Postal Code:  44060
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.

Essential Job Functions

1.   Lead the plant Quality staff to ensure compliance to the overall Quality Management System and to drive Continuous Improvement.

2.   Provide coaching, mentoring and leadership to the plant Quality staff.

3.   Lead and own the plant Management Review process.

4.   Ensure and drive compliance with the domestic regulatory and international standards and requirements.

5.   Lead the site’s quality improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/process quality dashboard.

6.   Manage the complaint handling processes to insure customer responsiveness and product and process improvements.

7.   Lead the quality plan development and execution for manufacturing site New Product Development ensuring successful product design transfer.

8.   Lead qualification and monitoring tasks for manufacturing site key suppliers to ensure effective supplier performance in the manufacturing process.

10. The position requires a level of authority to conduct and direct required activities.  Examples of this are: Quality planning, complaint management, production and process controls, CAPA management, supplier management and new product design transfer

11. Perform other duties as assigned.

Education/Requirements

The position requires a B.S. in Chemical Engineering, Microbiology or similar engineering field, or in other pertinent science or technical field. Advanced degrees or Quality Certifications are also desirable: CQE, CQA, CQMgr., Six Sigma or Lean. 

Work Experience Requirements

This position requires 5 – 10 years experience in a Manufacturing, Engineering or Quality/Continuous Improvement environment. Experience with supervision of technical and regulatory professionals is highly desirable. 

Supervisory Responsibilities

This is a middle management position involving the supervision of a small team, composed of either technical or professional employees. 

Desirable Skills

  1. Proven leadership ability to manage a team, make decisions and deliver results.
  2. Ability to solve problems at an operational and strategic level, manage multiple priorities and conduct data analysis.
  3. Working knowledge of IS0 9000 and FDA GMPs.
  4. Ability to set goals and meet project deadlines.
  5. Effective communication skills, both oral and written are required.
  6. Ability to establish and maintain an effective working relationship with subordinates, peers, and all levels of management.
  7. Experience with Class III or significant Class II devices 

Working Conditions

Manufacturing operations center

Laboratory with exposure to chemicals

Typical Office Setting

 

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:  11484
Category:  Quality
City:  Mentor
State:  OH
Postal Code:  44060


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

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