Quality Specialist - Hamilton, OH

The Quality Specialist is responsible for monitoring and evaluating the progress of all project's, ensuring documentation is reported to the Quality Manager, and addressing customer complaints. This role involves collaboration with various departments to meet customer requirements, maintain ISO 9001 compliance, and support production processes.

Project Monitoring: Track progress on all projects and evaluating documentation, reporting findings to the Quality Manager.

* Issue Resolution: Review issues documented in a shared customer database with project stakeholders and ensure timely rectification within the allotted timeframe.

* Customer Complaints: Investigate customer complaints and manage them through their lifecycle, both internally and in customer portals.

* Cross Department Collaboration: Work with other departments to ensure customer requirements are clearly understood and that materials and equipment have appropriate documentation.

* Quality Management System (QMS): Support to maintain QMS for ISO 9001 compliance.

* Calibration: Perform calibration of equipment to ensure accuracy and reliability in measurements.

* Production Support: Collaborate with production teams to ensure quality standards are met during manufacturing processes.

* 8D Root Cause Analysis: Conduct 8D root cause analysis to identify and resolve quality issues effectively.

Quality Management System Maintenance: Responsible for the maintenance and reporting aspects of the quality management system, implementing policies and procedures to enhance quality awareness, process controls, and continuous improvement.

* Data Analysis and Process Improvement: Utilize strong data analysis, process improvement, and project management skills to generate, maintain, and report corrective actions, metrics, process mapping, SOPs, and standard work.

* Corrective Actions: Facilitate, monitor, evaluate, and work with department managers to complete assigned corrective actions and verify their effectiveness.

* Metrics Reporting: Provide data inputs to assist in communicating metrics reporting for the facility and the entire CMC organization regarding the state of quality.

* ISO-9001 Compliance: Audit existing and new ISO-9001 processes/procedures for compliance based on ISO requirements and audit history.

* Quality Terminology and Methodology: Possess working knowledge of quality terminology/methodology, AQL sampling, trends, operation of measurement devices (e.g., optical comparator, CMM), six sigma, SPC, metrology practices, DOE, etc.

* PPAPs/FAI: Knowledge and implementation of PPAPs/First Article Inspection to assist in changing management of manufactured products, ensuring effective deployment and completion of PPAPs/FAIs.

* Technology and Equipment: Passionate about new technology and simplifying quality practices through acquisition/utilization of new equipment supporting the AFE process.

* Supplier Quality Data: Assist in maintaining supplier quality data, provide inputs for supplier scorecards, and leverage SAP where applicable. Visit supplier locations as needed.

* Continuous Improvement: Develop and facilitate continuous improvement activities to streamline critical quality processes and create flow/organization within the quality department.

* PFMEAs/Control Plans: Create PFMEAs/Control Plans by product family to ensure preventive measures are taken to prevent recurrence of quality issues.

* Additional Duties: Perform other duties as assigned.

Education: Bachelor's Degree (B.A., B.S., B.E.) from a four-year college or university in Business, Engineering, Operations, Process, Quality Assurance, or Science discipline.

* Experience: 6-10 years of quality experience, or an associate's degree with 2-4 years of relevant experience.

* Preferred Experience: Minimum of three (3) years' experience with SAP is highly preferred.

* Audit Experience: Experience in leading internal company audits and supplier audits is helpful; certification as lead or internal auditor is advantageous.

* Data Proficiency: Intermediate to advanced proficiency in data collection and analysis is required.

* Presentation Skills: Proficient in creating presentations, facilitating/delivering training, and public speaking.

* Statistical Tools: Must be able to use have a working knowledge of SPC.

* Certifications: Certified by ASQ (American Society for Quality) as a Quality Engineer is a plus.

* Manufacturing Experience: Prior experience in manufacturing is helpful.

* Travel: Ability to travel up to 10% is necessary.

* Language Skills: Bilingual in French, Spanish, or both languages is a bonus.