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Description

- Develops, implements, and maintains quality management systems (QMS) to ensure compliance to relevant industry standards such as ISO13485, 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.

Skills

erp system, lean manufacturing, excel, iso 13485, sap

Top Skills Details

erp system,lean manufacturing,excel

Additional Skills & Qualifications

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

Experience Level

Expert Level

Pay and Benefits

The pay range for this position is $80000.00 - $100000.00/yr.

Company BenefitsPaid Time OffBereavement LeaveCompany-paid Short-Term and Long-Term DisabilityESOPHolidays: 8 standard, 3 floatingPTO: 7 days (when tenure is under a year), 12 days (when tenure is a year or more)HSAFree life insurance policyProfit sharing

Workplace Type

This is a fully onsite position in Wooster,OH.

Application Deadline

This position is anticipated to close on Nov 4, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.