Quality Engineer II

STERIS • Plymouth, MN

8h • $84,363 - $109,175

About The Position

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 II 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. This position will be focused on and leading within the QMS space. This included mentoring others on the QMS processes/systems, document control, and audit support.

Requirements

• Bachelor's Degree in Engineering.
• Minimum of 3 years of related experience required. (Manufacturing/Quality Engineering and/or Quality Systems)
• 3+ years of experience working in an ISO certified environment

Responsibilities

• Participate on cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
• Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis.
• Initiate and/or participate in process and product corrective actions and problem-solving activities.
• Update/establish documented work instructions as needed.
• Review collected data to perform statistical analysis and recommend process/product changes to improve quality.
• Monitor and report on performance metrics.
• Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborate with other departments and facilities within the company on quality related issues.
• Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
• Perform quality system audits and provide guidance on corrective actions.
• Perform other duties as assigned.

Benefits

• This position is eligible for bonus participation.
• STERIS offers a comprehensive and competitive benefits portfolio.
• Click here for a complete list of benefits: STERIS Benefits
• STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees