Quality Engineer

3 days ago

Lahore, Punjab, Pakistan Byonyks Pvt Ltd Full time 840,000 - 1,320,000 per year

We're Hiring - Quality Engineer (Mechanical) (02 Positions)

Location: DHA Phase 3, Lahore

Experience: Fresh to 2 years

Department: QA/RA Department

Position Summary:

We are seeking a highly motivated and detail-oriented Quality Engineer (Mechanical) to join our Quality Assurance and Regulatory Affairs Department. The ideal candidate will ensure that our medical devices comply with applicable ISO 13485 and FDA 21 CFR Part 820 quality management system (QMS) requirements. This role focuses on process and product quality assurance—not quality control or calibration activities.

Key Responsibilities:

  • Develop, implement, and maintain quality system processes in alignment with ISO 13485 and FDA 21 CFR Part 820 requirements.
  • Support the creation, review, and continuous improvement of Standard Operating Procedures (SOPs), work instructions, and quality documentation.
  • Participate in risk management activities (e.g., per ISO 14971), including FMEA and design risk analysis.
  • Collaborate with cross-functional teams (R&D and Manufacturing) to ensure design and process validation are compliant with regulatory standards.
  • Lead and support internal audits and prepare for external audits by regulatory authorities and certification bodies.
  • Manage CAPA (Corrective and Preventive Actions), non-conformance investigations, and root cause analyses to prevent recurrence of issues.
  • Ensure change control processes are effectively implemented and documented in compliance with regulatory requirements.
  • Support document control and ensure that device history records (DHR), design history files (DHF), and technical files are maintained properly.
  • Contribute to supplier quality management activities, including supplier qualification, performance monitoring, and audits.
  • Participate in post-market surveillance and complaint handling processes as required.
  • Assist in regulatory submissions and compliance reviews related to product development and lifecycle management.

Qualifications:

  • Bachelor's degree in Mechanical Engineering or a related engineering discipline.
  • Fresh to 3 years of experience in quality assurance within the medical device or regulated manufacturing industry.

Skills and Competencies:

  • Excellent documentation skills with the ability to prepare, review, and maintain quality records in compliance with regulatory standards.
  • Highly proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) for data analysis, reporting, and documentation.
  • Strong analytical and logical thinking capabilities to identify issues, interpret data, and propose effective solutions.
  • Highly detail-oriented with exceptional accuracy in reviewing technical and quality-related documentation.
  • Excellent attention to detail and organizational skills to ensure compliance with ISO 13485 and FDA 21 CFR Part 820 requirements.
  • Logical thinker with the ability to approach problems methodically and ensure sound decision-making based on evidence and data.

Why Join Us?

  • Work on cutting-edge R&D projects with real-world impact
  • Collaborative and innovation-driven engineering environment
  • Fuel Card provided for commuting support
  • Comprehensive Health Coverage – including OPD, IPD, and Life Insurance
  • Leave Encashments every quarter
  • Opportunities for continuous learning, growth, and cross-functional exposure

Job Type: Full-time

Pay: Rs70, Rs110,000.00 per month

Education:

  • Bachelor's (Required)

Location:

  • Lahore (Required)

Work Location: In person

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