Quality Improvement Engineer

Quality Improvement Engineer

The Quality Improvement Engineer will be required to lead root cause problem solving and resolution of top GQO quality issues. This team member will coordinate and lead the investigation to identify potential failure modes and risks, the development of quality assurance practices and controls for Stryker products, and tracking of NC/CAPA core quality metrics. The CAPA Engineer will be expected to build relationships with several different functional groups and implement product improvements and process controls to enhance product quality.

Qualifications/Work Experience

-Fully support the Quality Policy by building quality into all aspects of work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training);

-Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements;

-Lead the implementation of assurances, process controls, and CAPA designed to meet or exceed internal and external requirements;

-Coordinate Stryker Sustainability Solutions' Non-conformance program, including:

•Acting as site Subject Matter Expert for Root Cause Analysis,
•Lead NCRB/CRB meetings,
•Assist/Interface with NC owners on Investigations, Action Plans, and Verification/Validation Activities,
•Assure proper root cause analysis for all GQO nonconformities,
•Monitor Problem Statements, Containment, RCA, Corrections/CAs/PAs, time lines, and required updates,
•Ensure all GQO NC files are established, maintained in a timely & organized manner, well documented, and closed properly,
•Identify & trend appropriate metrics and present defined reports to appropriate review boards (NCRB, CRB, Management RB),
•Lead and manage quality improvement projects,
•Aid in internal audits and audit support,
•Conduct supplier audits, as needed,
•Support Divisional Quality Systems.

QUALIFICATIONS:
•Ability to work with individuals across all levels of the organization, including management and customers.

•Strong written and oral communication skills.

•Strong team leadership skills.

•Excellent data collection, management and reporting skills.

•Manage time and resources effectively thorough good organizational skills and thorough use of positive problem solving skills.

Education and/or Special Training

•Bachelor's degree in Engineering or related field; 2-5 years experience desired.

•Extensive knowledge of FDA & ISO regulations a must;

•Experience with Root Cause Analysis techniques and application of those techniques;
•Experience in statistical analysis preferred;
•Knowledge of data analysis techniques (ASQ Green Belt a plus);
•Experience in Quality System and/or CAPA preferred;
•Certified Auditor a plus, ASQ Certifications a plus.

Percent Travel Required

10%