Quality Manager

3 weeks ago

Carlsbad, United States SpiTrex - 3D Full time
Job DescriptionJob DescriptionSalary: $85,000 to $145,000

Ready to Transform Your Career? Join SpiTrex 3D

Are you looking to be part of a dynamic team in the cutting-edge world of additive manufacturing? Do you thrive in a fast-paced, growing environment that blends high technology and USA manufacturing? If so, we have the perfect opportunity for you


We are a leading additive manufacturing company located in vibrant California. Our innovative solutions are revolutionizing the industry, and we're seeking an experienced technical Quality Manager to join our growing team. Imagine a workplace where your growth knows no bounds - where data drives success, and your career flourishes. We believe SpiTrex 3D is a workplace like no other. It is a place to be challenged, explore your curiosity, and grow your career. 


Job Overview:

 

The Quality Manager is responsible for overseeing and implementing quality control processes, procedures, and inspections to maintain and improve product quality while continuously expanding our manufacturing capabilities. Your focus will be on developing and implementing quality control measures, supporting product verifications, and collaborating with cross-functional teams to drive continuous improvement in the additive manufacturing operations. This position plays a crucial role in ensuring products or processes are consistent in quality, meet customer expectations, comply with industry standards and regulations.  These efforts contribute to reducing defects, minimizing rework, and enhancing overall product reliability and customer satisfaction.

 

Roles/Responsibilities:

  • Company Culture and Mission:
    • Consistently apply core values (Integrity, Impact, Dedication) to your decision-making process and interactions with others. Use the core values to guide your behavior and help to make choices that align with the organizational mission.
    • Uphold and contribute to the company’s quality policy commitment through continuous improvement efforts, customer focus, team collaboration and compliance.
  • Validation and Verification Testing:
    • Develop IQ/OQ/PQ protocols to validate the performance and functionality of equipment, processes or systems used in the manufacturing environment.
    • Execute validation tests and document results to demonstrate that the equipment or process meets established criteria.
    • Conduct risk assessments to identify potential issues and their impact, taking corrective actions to mitigate risks.
    • Compile validation reports summarizing the results of validation activities including any deviations and corrective actions.
  • Quality Control Inspections:
    • Support and perform regular inspections of raw materials, components, and finished products to verify compliance with quality specifications and standards.
    • Use various inspection tools and equipment such as Keyence Vision System, gauges, calipers., etc. to measure and assess product attributes.
  • Quality Control Processes:
    • Develop and implement robust quality control procedures, work instructions and job aids.
    • Ensure product processes adhere to established quality standards and guidelines.
    • Monitor and document data throughout the production process.
  • Defect Detection/Nonconformances:
    • Identify and document defects, nonconformance’s, or deviations from quality standards.
    • Work closely with quality leadership and production teams to address and resolve quality issues promptly.
    • Implement corrective actions to prevent recurrence of defects.
  • Statistical Analysis:
    • Apply statistical tools and techniques to analyze data and make informed decisions about the quality products and processes.
    • Use methods such as statistical process controls (SPC) and design of experiments (DOE).
  • Calibration and Maintenance:
    • Schedule and record calibration and preventive maintenance of equipment to ensure accuracy and reliability.
  • Documentation and Reporting:
    • Participate in root cause analysis and continuous improvement activities.
    • Use statistical methods and quality tools (e.g., Six Sigma, Pareto analysis) to identify opportunities for process enhancement.
    • Implement quality improvement initiatives to reduce defects and improve efficiency.
  • Training and Education:
    • Train and educate production and quality assurance personnel on quality control procedures and best practices.
    • Stay updated on industry trends, quality standards, and regulations.
  • Communication
    • Effectively communicate quality related information to supervisors, colleagues, and other relevant stakeholders.
  • Compliance
    • Ensure products and process comply with industry standards, regulatory requirements, and company quality standards,
    • Assist in the implementation of the quantity management system.
  • Continuous Improvement
    • Contribute to continuous improvement initiatives to enhance the efficiency and effectiveness of quality control processes. Complete assigned tasks associated with process improvements.

 

 

Education and Experience:

  • Bachelor’s degree in engineering or a related field (e.g., mechanical engineering, material science, industrial engineering) and 4-8 years relevant experience required. Masters of Science preferred. 
  • Additional 3-8 years of working experience in quality control or related role preferred. 
  • Experience with quality control software and data analysis tools preferred. 
  • Six Sigma Certified, Black Belt preferred.
  • Management experience preferred.

 

Competency:


  • Knowledge of ISO 13485 Quality Management System and FDA CFR 820 Quality System Requirements (QSR)
  • Strong knowledge of quality control principles, methods, and tools.
  • Proficiency in using measurement and inspection equipment.
  • Detail-oriented with excellent problem-solving skills.
  • Effective communication and teamwork abilities.


Benefits Include:

Medical, Vision and Dental Insurance
Short Term Disability
401(k) plus match
Vacation days
Paid holidays



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