Quality Engineer - Mentor, OH, US,
2 days ago
Job 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 Quality Engineer designs, installs and evaluates quality assurance process systems, procedures and statistical techniques; plans, conducts, and follows up on supplier audits; recommends revision of specifications when indicated; assists in the development, maintenance and improvement of the organization's overall supplier quality system in accordance with the requirements of ISO, FDA QSR and STERIS policies.
May conduct training on quality assurance concepts and tools. Interfaces with all other engineering components within the company and with customers and suppliers on quality related issues.
Duties
Major responsibilities of the role would include but are not limited to, (a) leading supplier quality improvement projects to drive improvement in supplier cost, quality and delivery, (b) driving improvement to supplier quality measurement and scorecard systems, (c) leading general product quality improvement efforts to drive improvement to key quality metrics, and (d) leading production and business process improvement efforts cross-functionally in the business.
2. Drive improvement in key quality metrics as measured by the product/process SQDC program
Coordinate improvement projects such as projects, complaint investigations, CAPA, raw material trends, and other continuous improvement actions.
Assist in creating, maintaining and improving overall Quality System integrity to ensure compliance to ISO and QSR standards.
Drive timely and effective root cause analysis and provide quality engineering leadership to suppliers.
Address and resolve supplier quality issues.
Directly support the customer complaint management process and assist in resolution in accordance with customer needs and compliance standards as it relates to suppliers.
Serve as quality engineering support to new product development design, testing, and introduction ensuring the attainment of key quality deliverables and quality targets.
Conduct material improvement team meetings. Resolve disputes and reach consensus on actions to be taken.
Oversee Approved Supplier List, Supplier Quality agreements/questionnaires, and establishing yearly critical supplier schedule.
Perform all other duties as assigned.
Education Degree
- Bachelor's Degree in Engineering General or Science
Required Experience
years' experience with manufacturing processes (such as Chemical, formulation, molding, and assembly.)
years' experience in quality systems, science, or engineering.
Excellent problem-solving skills including FMEA or root cause analysis and implementation of Supplier Corrective and Preventive Actions.
Leadership ability to coordinate projects in a cross-functional team environment.
Demonstrate effective organizational, oral and written communications skills
Demonstrated computer skills and experience with applications such as EXCEL, Minitab, Word.
#LI-BN1
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 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 § 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.
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