QC Supervisor

2 weeks ago

Allen, United States Actalent Full time
Description:
The QC Supervisor involves managing the scheduling of Quality Control Technicians, providing daily leadership and support, ensuring customer satisfaction through project prioritization and inspections, conducting training for effective QC activities, collaborating with cross-functional teams on process improvements, CAPA, and projects, and assisting in root cause investigations for non-conformances and customer complaints.
General Duties and Responsibilities:
  • Lead and execute QC activities across various areas, surpassing Key Performance Indicators (KPIs) in Labor Throughput, Inventory Accuracy, On-Time Metrics, and Overtime Hours.
  • Regulatory Compliance:
  • Ensure adherence to industry regulations (FDA, ISO 13485, etc.) in all QC operations, maintaining the highest quality standards.
  • Data-Driven Improvement:
  • Analyze QC data to identify trends, issues, and improvement opportunities. Present comprehensive reports to management, fostering a culture of continuous improvement.
  • Efficient Task Management:
  • Utilize Task Scheduling System for daily QC activities, guaranteeing accuracy in Enterprise Resource Planning (ERP) transactions.
  • Process Enhancement:
  • Identify and implement process improvements in QC and manufacturing, enhancing product quality and operational efficiency.
  • Team Leadership:
  • Provide effective leadership to QC Technicians, ensuring accurate inspections aligned with SOPs and promoting a culture of excellence.
  • Document Management:
  • Oversee the review, archiving, and accuracy of Device History Records (DHR). Implement corrective actions for documentation errors.
  • Inventory Oversight:
  • Manage inventory levels, conduct periodic cycle counts, and provide valuable feedback to Quality Management and cross-functional teams.
  • Environmental Monitoring:
  • Oversee the ISO Class 8 Cleanroom Environmental Monitoring Program, ensuring compliance with internal procedures.
  • Training and Mentoring:
  • Train and mentor QC personnel on procedures, regulatory requirements, and best practices, fostering a culture of continuous improvement.
  • Conduct regular audits of QC areas, ensuring compliance with internal standards. Act on findings and execute corrective actions.
  • Performance Management:
  • Write and execute performance reviews for QC personnel, ensuring continuous professional development.
  • Supplier Collaboration:
  • Collaborate with the procurement team to assess and monitor supplier quality and performance.
  • Continuous 5S Environment:
  • Execute and maintain a 5S environment in all QC areas, contributing to a well-organized and efficient workspace.
  • Documentation Improvements:
  • Collaborate with QA Management to make continuous improvements to all inspection documentation.
Skills:
  • Quality control
  • Quality assurance
  • Document control
  • six sigma
  • Inspection,
  • Iso 13485
  • CAPA
  • Root Cause
  • Audit
  • Lean
Additional Skills & Qualifications:
  • A minimum of 5 years in quality control within the medical device or pharmaceutical manufacturing industry, including at least 2 years in a supervisory or leadership role.
  • Bachelor's degree in a scientific or engineering discipline, demonstrating a strong foundation for the role.
  • Proven strong leadership and team management abilities, essential for driving excellence in quality control operations.
  • Proficiency in statistical analysis and adept use of quality control tools, showcasing a data-driven approach.
  • In-depth knowledge of regulatory frameworks such as MDSAP, FDA Quality System Regulation, MDD, and/or ISO 13485, ensuring compliance with industry standards.
  • High-level organizational skills to effectively manage personnel, ensuring the achievement of goals and tasks.
  • Exposure to test and quality assurance documentation practices, highlighting familiarity with quality processes.
  • Intermediate computer literacy in Word, Excel, and Access, showcasing the ability to navigate essential tools for the role.
  • Excellent communication skills, coupled with detail-oriented and strong deductive problem-solving abilities.
  • Knowledge and understanding of ERP Software (JDE or similar) and Inventory Management, contributing to operational efficiency.
Preferred Skills and Qualifications:
  • Certification as a Quality Engineer (CQE), Quality Auditor (CQA), or similar qualifications are preferred, reflecting a commitment to professional excellence.
  • Six Sigma Green Belt or higher is preferred, indicating proficiency in process improvement methodologies.
  • Preferred experience in ISO Cleanroom and EO Sterilization, showcasing specialized knowledge in critical areas.
Experience Level:
Intermediate Level
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.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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