Job Description
We are seeking a dedicated and experienced Quality Manager to oversee and enhance our ISO management system, internal processes, and quality assurance efforts. This role is critical in ensuring compliance with ISO standards, managing internal audits, conducting reviews, and leading quality initiatives to improve overall product and service quality. The Quality Manager will also handle aspects of DMR/RMA management, calibration, inspections, PPAP/FAIR documentation, and employee training and development.
ResponsibilitiesReview, update, and maintain ISO procedures and work instructions as necessary.Ensure organizational compliance with ISO standards, particularly ISO Medical Certification.Manage and schedule internal audits, ensuring thorough preparation and follow-up actions.Conduct periodic management reviews to assess the effectiveness of the quality system.Coordinate and facilitate all ISO audits, ensuring timely and organized scheduling.Develop, maintain, and distribute metrics reports, presenting them at PMR meetings.Ensure each department manager is responsible for generating their own metrics.Perform monthly DPPM (Defective Parts Per Million) calculations and analyze trends.Work with teams to reduce scrap, mistakes, and improve quality metrics across all operations.Manage and track all DMR/RMA documentation.Present a list of open DMRs/RMAs at weekly production meetings to discuss resolution and next steps.Log Corrective Action Requests (CARs) in the Corrective Action log.Collect internal responses and complete CAR documentation for customer submission to address quality issues.Oversee internal calibration of all company-owned and employee-owned devices within company capabilities.Coordinate with external suppliers for calibration services for items outside the company's capabilities.Perform inspections on incoming purchased products and services, including paint, plating, machining, etc., per the receiving inspection sample plan.Support department leads in verifying setups for new production runs.Assist in first-piece inspections when multiple setups are required, ensuring no downtime or backlogs occur.Train department leads on setup verification.Train operators to verify the quality of their own work during production.QA personnel will provide secondary verification through process audits throughout the day.Utilize Discuss software to balloon prints for dimensional data capture.Create and maintain an Excel master file for dimensional data tracking.Complete all necessary documents within the workbook to meet customer requirements.Provide training for operators, focusing on print reading, understanding key areas of prints, and ensuring focus on critical quality attributes.Support QA personnel in continuous development and training.Advise on the procurement and implementation of new quality-related equipment.Stay current with quality management best practices and technological advancements.Essential SkillsBachelor's degree in a related field (e.g., Engineering, Manufacturing, Quality Management).Minimum of 5-8 years of experience in a quality management role, preferably within a manufacturing or medical device industry.In-depth knowledge of ISO standards, particularly ISO Medical Certification.Experience with ERP systems for RMA/DMR management.Strong knowledge of calibration processes and inspection techniques.Excellent analytical, problem-solving, and communication skills.Ability to lead cross-functional teams and provide quality-focused training.Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) and experience with quality management software tools.Additional Skills & QualificationsExperience in fabrication and related processes.Proficiency in PPAP/FAIR, first article inspection, inspection control.Knowledge of SCAR, corrective action plans, MRB, DMR, metrics.Work Environment
The work environment is a brand new facility in Saint Charles, which is temperature controlled. The Quality Manager will have an office space to facilitate their duties.
Pay and Benefits
The pay range for this position is $80000.00 - $110000.00/yr.
4% 401k Match
7 Paid Holidays
2-3 Flex Holidays
Workplace Type
This is a fully onsite position in Saint Charles,IL.
Application Deadline
This position is anticipated to close on May 19, 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 actalentaccommodation@actalentservices.com for other accommodation options.