Senior Quality Engineer in Mentor OH

Full-time @Steris in Engineering , in Healthcare , in Manufacturing Engineer , in Medical Device , in Medical Device Engineer , in Quality Engineer , in Senior Quality Engineer
  • Mentor, OH, US, 44060 View on Map
  • Apply Before : November 15, 2022

Job Description

Join Steris as Senior Quality Engineer in Mentor Ohio. At the Steris you will perform tasks as listed below, Apply Steris Quality careers in Mentor OH.

 

Position : Senior Quality Engineer

Job Category: Quality

Work location : Mentor, Ohio

Job Segment : Senior Quality Engineer, Medical Device Engineer, Quality Engineer, Medical Device, Manufacturing Engineer, Engineering, Healthcare

 

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 Senior Quality Engineer is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards.  This role leads complaint/CAPA investigations, supplier quality improvement actions, operations production and process control improvements, and product and service quality improvements with the use of statistical techniques and other accepted quality principles.  This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

We offer a comprehensive benefits package, including:

Competitive pay
Annual merit and bonus plans
Training and coaching
Medical, vision, dental and life insurance
401(k) with a company match
Paid vacation time and paid holidays
Tuition assistance
Opportunities for advancement

Duties

Serves as the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.
Develops and implements statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.
Leads process and product corrective actions and problem-solving activities.
Reviews the current quality system and recommend / implement improvements as needed.
Uses data to perform statistical analysis and recommend process / product changes to improve product and service quality.
Leads projects focused on quality system, product quality and service quality improvements.
Develops analyses and reports on the performance of the quality system.
Leads supplier audits and corrective actions.
Leads and supports internal and external quality system audits.
 Instructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
Collaborates with other departments and facilities within the company on quality related issues.
Supervises Quality Engineers and/or other Quality staff in the execution of their assigned duties and objectives.
Maintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes.
Perform all other duties as assigned. 

Duties – cont’d
Education Degree
Required Experience

Bachelor’s Degree in Engineering or related technical field.
6+ years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
6+ years of experience working in an ISO certified environment.
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, and PowerPoint.

Preferred Experience

Experience with statistical analysis software and Visio.
6+ years of experience with medical device or other regulated industries.
ASQ, QSR or familiarity with QSR/GMP regulations preferred.

Skills
 

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.

Nearest Major Market: Cleveland

Nearest Secondary Market: Akron

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Required skills