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Quality Assurance Manager

1 month ago

Melbourne, Florida, United States OnDek Solutions Full time
Job Title: Quality Assurance Manager

We are seeking a highly experienced Quality Assurance Manager to join our team at OnDek Solutions. The successful candidate will be responsible for overseeing and managing the performance of our quality management system, ensuring compliance with ISO 9001, ISO 13485, and AS 9100 standards, as well as regulatory requirements.

Key Responsibilities:
  • Develop, implement, and maintain the company's Quality Management System (QMS) in alignment with industry standards.
  • Perform internal audits, identifying areas for process improvement, and ensuring adherence to all relevant quality and regulatory standards.
  • Set quality goals, monitor customer feedback, and collaborate with production teams to improve product reliability and reduce costs.
  • Lead Root Cause Analysis initiatives across the organization.
  • Administer the corrective action process to ensure timely resolution and closure of Corrective Action Requests (CARs).
  • Organize and deliver training programs focused on quality and reliability.
  • Drive supplier quality improvement programs.
  • Maintain regular communication with customers to ensure their quality standards and objectives are met.
  • Provide regular updates to Senior Management on the performance of the Quality System.
  • Collaborate with Program Management and Sales during the onboarding of new customers.
  • Manage the quality department's budget efficiently.
  • Lead document control efforts and ensure calibration and ESD activities are properly managed.
  • Champion Continuous Improvement initiatives by forming and leading Quality Teams.
  • Support company-wide Continuous Improvement and Best Practice initiatives.
  • Actively participate in site management meetings and collaborate on strategic decisions.

Qualifications:

  • Bachelor's degree in Electrical, Mechanical, Industrial Engineering, or a related technical field.
  • At least 8 years of experience in implementing and managing ISO 9000 systems.
  • A minimum of 5 years of hands-on experience with SMT and box build operations in a contract manufacturing setting.
  • Proven experience managing teams, budgeting, and working with various business systems and software.
  • A minimum of 3 years of experience with AS9100 or ISO 13485 is highly desirable.
  • Preferred certifications include CQM, CQE, or ISO lead auditor.
  • Expertise in Root Cause Analysis with a track record of successful change implementation.
  • Six Sigma Green or Black Belt certification is advantageous.
  • Proficiency with business software (Excel, MS Word, Email, etc.).
  • Experience in high-volume PCB assembly operations is essential.
  • Familiarity with conducting internal and third-party audits.
  • Capable of hosting customer visits and ensuring their quality requirements are met.
  • Strong organizational, communication, time management, and problem-solving abilities.
  • Experience fostering team collaboration and a positive work environment.
  • Ability to thrive in a fast-paced, high-pressure setting with multiple priorities.
  • Must have ISO 9001 experience.
  • Willingness to adjust work hours when necessary.