Quality Engineer
Katalyst HealthCares & Life Sciences
Quality Assurance Manager
Ownership includes both quality assurance and quality control. Includes quality assurance of products, services and manufacturing processes. Includes conformance in manufacturing, incoming goods control, product inspection, witness points, etc.
Develop and implement robust quality plans and processes.
Identify and drive Continuous Improvement (CI) with Corrective/Preventative Actions.
Review and determine disposition of nonconforming inventory.
Assists in resolving internal and external quality problems utilizing proven methods.
Completes and maintains all first article inspection and product audits for assigned programs.
Authors, reviews, and updates manufacturing and/or inspection instructions.
Contributes to team development through overall experience and knowledge.
Resolves issues using best known procedures and problem solving. Consults supervisor or more senior team members for issues outside of defined instructions/parameters.
Develops strong internal, supplier, and customer relationships. Acts as customer support focal point regarding Quality.
Ensures compliance to customer requirements (drawings, standards, purchase orders, quality certifications, etc.).
Executes failure analysis, troubleshooting, and feedback to the team.
Accountable for achieving ISO or other quality certifications within a set timeline.
Present reports and analyses of research, findings, or outcome of a project.
Ensures adherence to all safety procedures and good housekeeping standards.
Actively participate on Material Review Boards and Failure Review Boards, which includes disposition of non-conforming products, identifying containment requirements, and identifying appropriate root cause and corrective actions to prevent recurrence.
Focal point for quality audits and follow-up for non-conformances.
Ability to read and interpret technical drawings with proficiency and working knowledge of Geometric Dimensioning and Tolerancing (ASME Y14.5 GD&T).
Interpret, review, analyze, and report on quality discrepancies and trends.
Strong written and verbal communication skills to both internal and external customers.
Communicates within and outside of own function to gain cooperation on operational processes, practices, and procedures.
Develop and conduct functional business-related risk assessments.
Track and report Business Quality Metrics to upper management.
Perform trend analysis to identify out of control conditions through Paretos, Lead RCCA, and 8D activities.
Zero defect planning and develop control or inspection plans with KQI's.
Thorough understanding of the requirements of AS / ISO and the ability to conduct audits.
Understanding of APQP - Advanced Product Quality Planning, SPC - Statistical Process Control, FMEA - Failure Mode and Effects Analysis, Risk Mitigation, Control and Inspection Plans.
Computer proficiency (Microsoft Excel, Word, PowerPoint, Minitab, SAP).
Implementation and oversight of First Article Inspection (FAI) Process.
Minimum 7+ years of technical experience.
Bachelor's degree or higher in a technical field including Mechanical Engineering, Materials Science, Chemistry, Chemical Engineering, Surface Science, Applied Physics, or equivalent.
Knowledge and ability to implement ISO certification in a new manufacturing facility.
Strong oral and written communication skills with excellent skills in the English language and grammar.
Work with Manager to continue development path.
Reports to an Operations Manager or head of department.
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