Quality Assurance Specialist

hace 2 meses

Paraíso, Paraíso, Costa Rica Heraeus A tiempo completo

About Heraeus


Heraeus is a global leader in the production and trade of precious metals and materials. We are a dynamic company with a long history of innovation and excellence.



Job Summary


We are seeking a highly skilled Quality Assurance Specialist to join our team at Heraeus. As a key member of our quality management team, you will be responsible for ensuring that our products meet the highest standards of quality and regulatory compliance.



Key Responsibilities



  • Develop and Implement Quality Control Plans: You will work closely with cross-functional teams to develop and implement quality control plans and processes that ensure compliance with regulatory requirements.
  • Lead Process Improvement Initiatives: You will lead and oversee process improvement initiatives to enhance product quality, reduce defects, and optimize manufacturing processes.
  • Collaborate with Cross-Functional Teams: You will collaborate with production teams, engineering, and other departments to identify and resolve quality issues and drive continuous improvement efforts.
  • Conduct Root Cause Analysis: You will conduct root cause analysis and implement corrective and preventive actions to address quality non-conformances.
  • Perform Risk Assessments: You will perform risk assessments and develop risk mitigation strategies to ensure product safety and efficacy.
  • Provide Training and Guidance: You will provide training and guidance to production teams on quality control practices and procedures.
  • Monitor Quality Performance Data: You will monitor and analyze quality performance data to identify trends and opportunities for improvement.
  • Serve as Quality System Champion: You will actively work within all aspects of the Quality System to provide supporting Value Stream Team.


Qualifications


To be successful in this role, you will need:



  • Bachelor's Degree: A bachelor's degree in engineering, science, or a related field.
  • Quality Management Experience: Knowledge of quality management systems, such as ISO and FDA standards, applicable to medical device manufacturing.
  • Statistical Analysis Skills: Experience with statistical analysis, process validation, and quality assurance methodologies.
  • Problem-Solving and Analytical Skills: Strong problem-solving and analytical skills, including familiarity with tools like FMEA, SPC, and DOE.
  • Excellent Communication and Interpersonal Skills: Excellent communication and interpersonal skills to collaborate effectively with internal and external stakeholders.
  • Risk Management and Regulatory Compliance: Understanding of risk management, CAPA processes, and regulatory compliance in the medical device industry.
  • ASQ Certification: ASQ certified Quality engineer a plus.
  • Technical Skills: Ability to utilize MRP or ERP software and Statistical Analysis Software. Proficient with Microsoft Office.


Salary Range


$85,000 - $110,000 per year, depending on experience.



About Heraeus


Heraeus is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.


Contact Information


Please submit your application through our website.

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