Operations Quality Manager - PRC-Saltillo : Job Details

At PRC-Saltillo, we have a mission to provide voices to children and adults who are unable to communicate effectively with their natural voices. Each year, we provide voices to thousands of individuals through our specialized communication devices and software. We serve individuals with Autism, ALS, Cerebral Palsy, Aphasia and a variety of other conditions. Our products not only provide the ability to speak, but open opportunities for education, vocation and simply fuller participation in life. All applicants need to go to our website to apply www.prc-saltillo.com/careers Position Summary: The Operations Quality Manager spearheads the implementation of strategies, processes, and procedures to ensure our products meet the highest quality standards and comply with all relevant agency requirements. This role is pivotal in driving continuous improvement through effective change management, implementing corrective solutions that enhance our operations. The Operations Quality Manager ensures customer complaints are promptly directed to the appropriate departments, resolved efficiently, and communicated effectively. This position is crucial in maintaining our commitment to quality and customer satisfaction. Duties and Responsibilities:

• Develops, implements, and maintains quality management systems (QMS) to ensure compliance to relevant industry standards such as ISO 13485, FDA or others as applicable.
• Interprets and ensures compliance with industry regulations, legal requirements, and customer specifications. Serves as a point of contact for external audits and inspections.
• Leads the development and optimization of operations and service processes for the production of electronics products.
• Develops and delivers training to employees at all levels on quality standards, procedures, and continuous improvement methodologies.
• Implements lean manufacturing practices, Six Sigma methodologies, and continuous improvement initiatives to increase productivity, reduce costs, and improve product quality.
• Collaborates with product development and engineering to ensure manufacturability and design for manufacturability (DFM) principles are followed.
• Leads, develops and mentors a team of process and quality engineers, providing guidance and training.
• Assigns tasks and ensures deadlines are met while fostering a collaborative and innovative environment.
• Conducts performance reviews and provides ongoing coaching to ensure the team's effectiveness
• Designs, implements, and maintains efficient operations processes.
• Leads troubleshooting efforts for operations issues, focusing on root cause analysis and the implementation of corrective actions.
• Coordinates with manufacturing, service, and maintenance, to address and resolve technical challenges on the shop floor.
• Works closely with suppliers to assure the quality of incoming materials and components.
• Manages customer complaints and non-conformance reports, working to resolve issues and ensure customer satisfaction.
• Collaborates with engineering to improve product designs and address any quality concerns.
• Maintains certifications and ensure all relevant processes and practices are up to date with applicable industry standards.
• Ensures that all processes meet quality standards and regulatory requirements and works to continuously error proof processes and to improve yield.
• Implements and maintains process control systems to monitor quality and efficiency.
• Works closely with technical service to employ best practices and effective fault coding for client interactions of all kinds.
• Monitors short- and long-term post market product and service performance.
• Ensures post market metrics and feedback are shared and used widely.
• Works with the operations team to develop cost-effective solutions without compromising quality or safety.
• Conducts cost-benefit analyses for new equipment, processes, and technology.
• Works closely with several internal departments to ensure smooth operations.
• Performs other duties as assigned.

• Demonstrated leadership and coaching skills in creating a team-oriented culture.
• Sound analytical and strong organizational skills.
• Strong command of MS Office products, especially Excel with the ability to extract, organize, manipulate, interpret and share large amounts of information.
• Ability to effectively delegate responsibility and coordinate a wide variety of activities.
• Strong knowledge of product costing.
• Knowledge of quality, manufacturing, procurement, shipping and technical service processes.
• Ability to create and maintain positive working relationships with clients, co-workers, and vendors/suppliers.
• Excellent written, verbal, and interpersonal communication skills.
• Self-starter with ability to work well under minimal supervision.
• Team player with ability to work well with all levels inside and outside the organization.
• Flexible and able to adjust to rapidly changing circumstances.

• Bachelor's Degree in Engineering, Quality Management, or related field is required. Master's degree or relevant certifications (CQE, CQM, Six Sigma Black Belt) is a plus.
• A minimum of 10 years' experience in manufacturing or related operations is required.
• At least 7 years of experience with progressive responsibility in Operations is required.
• At least 5 years' experience in an ISO (or related) quality management environment is required.
• In-depth knowledge of quality management systems, regulatory standards, and continuous improvement methodologies. Knowledge of ISO 13485 is a plus.
• Demonstrated success implementing business improvement initiatives including lean manufacturing programs is required. Continuous Improvement certification is preferred.
• Strong knowledge of an ERP system (at least 3 years) is required. SAP experience is preferred.