Quality Systems Manager

3 days ago

Siālkot, Punjab, Pakistan beBeeQuality Full time 2,500,000 - 4,500,000

Seeking a skilled Quality Assurance Specialist to support our operations in Sialkot, Pakistan. This role is crucial in ensuring compliance with international standards and regulations.

Key Responsibilities:
  • Maintain and implement quality management systems according to ISO 13485 and EU MDR.
  • Develop and maintain comprehensive quality documentation: SOPs, templates, work instructions, and records.
  • Support the development of technical documentation, including design history files, device master records, and process validation documents.
  • Conduct regular gap assessments and contribute to ongoing improvement initiatives.
  • Collaborate with cross-functional teams to ensure regulatory compliance.
Required Qualifications:
  • Bachelor's degree in engineering (preferably mechanical or metallurgical).
  • 1-3 years' experience in surgical or medical device manufacturing.
  • Thorough understanding of ISO 13485 and EU MDR requirements.
  • Familiarity with relevant industry standards, including ISO 14971, ISO 15223-1, and ISO 10993.
Key Competencies:
  • Strong analytical and problem-solving skills.
  • Ability to interpret complex regulatory texts.
  • Excellent written communication and documentation skills.

This is an on-site position based in Sialkot, Pakistan. Applicants must be currently living in Sialkot or nearby areas. The company does not provide accommodation.

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