Quality Engineer -Supplier

The Supplier Quality Engineer is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable standards. This role supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement with the use of statistical techniques and other accepted quality principles.This role executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems and supplier quality program. The Supplier Quality Engineer follows up on supplier audits and supplier nonconformances; recommends revision of specifications when indicated; and drives continuous improvement throughout the supply chain.

The Supplier Quality Engineer is a Hybrid position based out of Mentor, OH and requires up to 35% travel,both domestic and international (Mexico and Canada), to STERIS locations or supplier sites.

• Major responsibilities include (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.
• 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.
• 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.
• Conduct Supplier Audits and track resulting actions.

Required:

• Bachelor's degree in Engineering or related technical field.
• Minimum of 3 years' experience with manufacturing processes.
• Minimum of 3 years' experience in quality systems, science, or engineering.
• Minimum of 1 or more years of experience working in an ISO certified environment.
• Excellent problem-solving skills including FMEA or root cause analysis and implementation of Supplier Corrective and Preventive Actions.
• Ability to travel up to 35% including both domestic and international travel.

Preferred:

• 1-5 years of experience with medical device or other regulated industries preferred.
• ASQ, QSR or familiarity with QSR/GMP regulations preferred.
• Certifications in CQE or CQA, preferred.
• Master's degree, a plus.
• Experience in a medical device manufacturing environment and familiarity with ISO, QSR/GMP requirements, preferred.
• Experience in a lean, continuous improvement environment, preferred

Here is just a brief overview of what we offer:

• Market Competitive pay
• Extensive Paid Time Off and added Holidays
• Excellent Healthcare, Dental and Vision benefits
• Long- and Short-Term Disability coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add- on benefits / discounts for programs such as Pet Insurance
• Tuition Reimbursement and continuing education programs
• Excellent opportunities for advancement in a stable long-term career

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