Katalyst Healthcares and Life Sciences
Responsibiities:
- 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.
- ssists in resolving internal and external quality problems utilizing proven methods.
- Completes and maintains all first article inspection and product audits for assigned programs.
- uthors, 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.
- ccountable 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.
- ctively 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.
- bility 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.
- horough 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.