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Regulatory Compliance Expert

hace 2 meses

Valencia, Valencia, España Celestica A tiempo completo
About the Role

Celestica is seeking a highly skilled Quality Assurance Specialist to join our Healthcare Quality department in Valencia, Spain. As a key member of our team, you will be responsible for ensuring the quality of our medical devices and managing interactions with customers and technical issues related to our products.

Key Responsibilities
  1. Quality Planning: Develop and implement product quality plans to ensure compliance with regulatory requirements.
  2. Complaint Investigation: Conduct thorough investigations into customer complaints and coordinate corrective actions to prevent recurrence.
  3. CAPA Coordination: Collaborate with cross-functional teams to identify and implement corrective actions to address quality issues.
  4. Change Control Management: Manage and coordinate changes to products, processes, and documentation to ensure compliance with regulatory requirements.
  5. New Product Introduction: Participate in the development and implementation of new product introductions, ensuring quality and regulatory compliance.
  6. Engineering Changes: Coordinate and manage engineering changes to products and processes, ensuring compliance with regulatory requirements.
  7. Work Instructions and Line Support: Develop and maintain work instructions and provide support to production teams to ensure quality and regulatory compliance.
Requirements
  1. Fluent English: Excellent written and verbal communication skills in English.
  2. Technical Knowledge: Strong knowledge of mechanical, electrical, electromechanical, or bioengineering-biomedicine systems and principles of operations.
  3. Quality Standards: Knowledge of quality standards and problem-solving competency.
  4. Computer Skills: Proficient in personal computers and Windows applications.
  5. SAP: Familiarity with SAP is desirable.
  6. Communication Skills: Ability to effectively communicate with a variety of internal and external customers.
Education and Experience

1-2 years of experience in a quality assurance or regulatory compliance role. Bachelor's degree in Industrial Engineering, Electronics Engineering, or Biomedicine Engineering.

Celestica is an equal opportunity employer.