Quality Specialist (QPP OTD) I

• Monitor and maintain the quality system in accordance with the quality policy and procedures.
• Oversee and provide guidance on the application and interpretation of quality standards based on ISO 9001 and other relevant standards.
• Maintain and enhance the Quality Process Procedure (QPP) to ensure on-time delivery (OTD) metrics are met or exceeded.
• Evaluate, analyze, and report quality performance using statistical and analytical tools.
• Conduct internal audits to verify the effectiveness of the quality system and compliance with quality standards.
• Work cross-functionally with other departments to identify quality concerns and implement corrective actions as needed.
• Participate in the review and approval of engineering changes, product release processes, and ad-hoc engineering projects as related to quality assurance.
• Liaise with customers regarding quality issues, providing timely and effective solutions for customer complaints and problems.
• Continuously monitor supplier quality and performance, implementing improvement strategies as necessary.
• Develop and implement training programs to increase quality awareness and promote a culture of continuous improvement.
• Ensure preparation, execution, and documentation of validation protocols and reports.
• Support in the regulatory affairs and compliance, helping in the submission of regulatory filings and ensuring the organization meets all required compliance standards.
• Coordinate root cause analysis, identification and implementation of corrective and preventive action (CAPA) for non-conformity issues.

• Bachelor's degree in Engineering, Quality Assurance, or a related field.
• Minimum of 5 - 8 years of experience in quality control or quality assurance, preferably in a manufacturing environment.
• Strong understanding of ISO 9001 and other quality system standards.
• Knowledge of Quality Process Procedures (QPP) and On-Time Delivery (OTD) principles.
• Experience with advanced statistical and quality engineering tools such as SPC, FMEA, Six Sigma, Quality Circles, etc.
• Professional certifications, such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA), are preferred.
• Excellent problem-solving and decision-making skills to analyze quality issues and identify appropriate corrective actions.
• Strong verbal and written communication skills with the ability to effectively communicate with team members at all levels within the organization.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with quality management software systems.
• Customer-focused with experience handling customer complaints and problem resolution.
• Sound knowledge and experience with regulatory affairs and compliance requirements in a manufacturing environment.
• Experience in conducting internal audits and leading Quality Improvement projects.
• Self-motivated with a strong commitment to quality and continuous improvement.
• Ability to manage multiple tasks and priorities in a fast-paced environment.
• Awareness and experience with Risk Management principles and applications.

Hella