The Quality Manager is responsible for providing leadership and technical direction to production and engineering regarding quality compliance and process control while assuring that products meet customer requirements and processes continue to operate in accordance with company policies and procedures. Provide support for incoming, in-process, final inspection, and testing.
Ensure verification, validation, manufacturing and testing of products meets customer expectations, quality specifications, industry standards, and regulatory requirements.
Lead internal, customer, and regulatory audits.
Train and supervise staff in the use of quality tools and methodologies.
Essential Duties and Responsibilities:
Develop, implement, maintain, and continually improve a comprehensive quality management system (QMS) to ensure consistent product quality and compliance with regulatory and ISO standards.
Establish quality standards for products and processes and suggest modifications to prevent defects in components and final products.
Develop and initiate internal standards and processes for inspection, testing and evaluation Audit production processes, to ensure established quality standards are met.
Create and utilize risk mitigations tools, including, but not limited to process FMEA's, process control plans, and visual standards.
Develop plant COQ (Cost of Quality) metrics and tracking methodology
Create first article / PPAP submissions for customers.
Manage nonconformance. Conduct root cause analysis and coordinate implementation of corrective actions. Follow up to assure that corrective actions are in place and effective.
Measure parts, complete process capability studies, conduct statistical process analysis, interpret results, and make recommendations regarding dimensional part tolerances.
Develop and initiate quality control plans using engineering product drawings, process diagrams, and technical specifications to meet company requirements for ISO and customer requirements.
Analyze quality data, identify problem areas, and assist in improving manufacturing processes and methods that affect quality.
Participate in cross functional product launch activities. Lead the APQP process and establish quality plans that manage potential risks.
Maintain professional working relations and effective communication with all team members, managers, vendors, customers, and regulatory agencies.
Lead regulatory (ISO:13485:2016, FDA and cGMP) and customer audits.
Provide disposition of incoming, non-conforming materials in a timely manner and assure proper preventive actions are taken as needed.
Establish and implement supplier quality management system. Work with suppliers to reduce and eliminate defects.
Work with engineering and operations to develop methods and procedures for evaluation of processes and equipment to meet the required quality capability.
Maintain appropriate history and records of quality issues and process improvements.
Perform required equipment qualifications (EQ) and process qualifications (PQ).
Design, develop, and train employees in the ISO 13485:2016 quality program.
Engage and contribute to the continuous improvement activities by participating and providing thoughtful consideration and suggestions for improvements throughout our business.