Quality Assurance Coordinator

4 weeks ago

Siālkot, Punjab, Pakistan ErgoDenta ApS Full time

Job Title: QA Coordinator – Medical Devices (ISO 13485/MDR)

Location: Ugoki Sialkot

Industry: Surgical Instrument Manufacturing

Employment Type: Full-Time

We are seeking a proactive and detail-oriented QA Coordinator to support the development, implementation, and maintenance of our Quality Management System (QMS) and ensure compliance with ISO 13485, EU MDR, and other relevant standards and regulations, across our production site and Danish office.

Key Responsibilities:

·Assist in the implementation and maintenance of the QMS in compliance with ISO 13485 and EU MDR.

·Develop and maintain quality documentation including SOPs, templates, work instructions, and records.

·Support the preparation and maintenance of technical documentation (TD) including:

oDesign History Files (DHF)

oDevice Master Records (DMR)

oProcess validation documentation

oRisk Management files in line with ISO 14971

oGeneral Safety and Performance Requirements (GSPR)

oPost-Market Surveillance (PMS) plans and reports

oClinical Evaluation Reports (CER)

·Support internal audits and regulatory inspections.

·Conduct gap assessments and provide input for continual improvement.

·Collaborate with cross-functional teams for QMS and documentation compliance.

·Perform literature reviews, regulatory research, and data analysis as needed.

Required Qualifications:

·Bachelor's degree in Engineering (preferably Mechanical or Metallurgical).

·Minimum 1–3 years of experience in the surgical instruments or medical device manufacturing industry.

·Solid knowledge of ISO 13485 and EU MDR requirements.

·Working familiarity with related standards: ISO 14971 (Risk Management), ISO 15223-1 (Symbols), ISO 10993 (Biocompatibility).

·Experience in drafting and implementing SOPs and documentation tools across quality functions.

·Understanding of regulatory expectations around TD, validation, risk management, PMS, and CERs.

Key Competencies:

·Strong technical and analytical thinking.

·Good research skills and ability to interpret regulatory texts and standards.

·Excellent written communication and documentation skills.

·Highly organized, detail-oriented, and able to meet deadlines.

·Objective and result-driven with a proactive mindset.

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