Quality Engineer

State Industrial•Hebron, OH

About The Position

Responsible for managing and supporting the State Industrial Products Quality Management System (relating to but not limited to) plant and corporate quality, corrective actions, product and processes capability, change management, new product, and process launch, leading and supporting all ISO 9001 and GMP quality audits, serving as a quality technical resource to other functional areas, training the chemical Quality Lab team in the quality sciences, supporting the prioritization of continuous improvement with cross functional key business partners, and managing our Enterprise Quality Systems Software (Intellect).

Requirements

Bachelor’s degree in technical science
Minimum 3 years’ experience in a quality engineer role
Minimum 2 years maintaining a Quality Management system
Previous experience in usage and programming quality software preferred
Demonstrated proficiency in critical thinking skills along with the 7 basic quality tools
Demonstrated proficiency in continuous improvement methodologies
Proficiency in Microsoft office suite
Working knowledge of Minitab preferred
ISO 9001 Internal Auditor certification required
GMP certification preferred
Certified quality auditor (CQE) preferred
Six Sigma Green Belt preferred
Ability to collaborate with cross functional teams

Responsibilities

Solves problems and mentors others on effective problem solving by using a systematic analysis process and using industry standard methodologies (5 Why, Fishbone, Pareto, DMAIC).
Finds the assignable cause; aids in implementing robust, data-based solutions; identifies the systemic root causes and ensures actions to prevent problem reoccurrence.
Manages CAR and SCAR system and assures root cause correction and follow up on all items.
Assists Corporate Quality Director with all plant and corporate Internal and External ISO 9001 and GMP audits; assures all departments follow up and apply permanent corrective action to findings.
Leads and supports all internal audit activity for both ISO 9001 and GMP.
Acts as Management representative for all external audit activity.
Assists Corporate Quality Director with leadership of SIP continuous improvement activity with cross functional key business partners by using industry proven methodology.
Assists QC Lab and assures focus on CTQ (Critical to Quality) activities such as batch release and raw material Quality Assurance.
Conducts testing in the laboratory when necessary.
Trains Quality Chemical lab personnel in the quality sciences.
Monitors and reports all key performance indicators to corporate leadership and stakeholders.
Manages and trains others on usage of Intellect (SIP Enterprise industrial software).