Quality Engineer I

Steris Corporation•Eden Prairie, MN

7d•Onsite

About The Position

The Quality Engineer I in our Eden Prairie, MN location is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: ISO 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 requires that you work onsite in our Eden Prairie facility Monday through Friday during core business hours 7am to 4 pm or 8am to 5pm. Must be available for occasional early morning calls with team in Germany.

Requirements

Bachelor's Degree in Engineering.
Minimum of 1 year of related experience required (combined Manufacturing/Quality Engineering/Quality Systems experience or minimum of 6 months on-site STERIS internship or co-op experience.)
Minimum of 1 year of experience working in an ISO certified environment.
Experience with medical device or other regulated industries.

Nice To Haves

ASQ, Certification, preferred.
Quality Management System Regulation FDA (QMSR) Certification or familiarity with QMSR/GMP regulations.
Knowledge of TrackWise ,Windchill PLM, Grand Avenue or other similar systems.
Experience with supplier controls, supplier audits or supplier monitoring.
Knowledge of ISO 13485.

Responsibilities

Participate in cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
Develop and implement statistically valid sampling plans, design 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.