Supplier Quality Engineer I

Medivators Inc.•Plymouth, MN

11d•$80,000 - $95,000•Onsite

About The Position

The Supplier Quality Engineer I in our Plymouth, MN location 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 requires working onsite in our Plymouth, MN location between the hours of 8am to 5pm. The Supplier Quality Engineer role will require travel up to 10% domestically to visit supplier sites.

Requirements

Bachelor's Degree in Engineering.
Minimum of 1 year of related experience (Manufacturing/Quality Engineering and/or Quality Systems), required.
Minimum of 1 year of experience working in an ISO certified environment.
Ability to travel domestically up to 10 %.

Nice To Haves

Experience with medical device or other regulated industries, preferred.
Experience with ISO13485 strongly preferred.
Experience with Supplier Quality working with production suppliers impacting product quality is strongly preferred.
Certification with ASQ, QSR or familiarity with QSR/GMP regulations, preferred.
Experience with SAP, preferred.
Experience with Quality Management Systems (QMS), preferred.
Experience with Data Analytics, preferred.
Experience with statistical analysis software and Visio, preferred.

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, 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 supplier audits and quality system audits; provide guidance on corrective actions.
Perform other duties as assigned.