Job Description:
We have an established QMS and MDR-specific SOPs already in place, and a designated internal team managing BSCI. We’re looking for a hands-on Compliance Document Control Specialist to compile, format, file, track, and maintain all required documentation to keep us audit-ready for EU MDR and BSCI. This role is ideal for someone meticulous and process-driven who can turn inputs from our teams into clean, complete, and compliant records.
Key Responsibilities:
- Maintain, organize, and update MDR documentation packages: procedures, SOPs, work instructions, forms, records, and logs in our document control system
- Build and maintain the Technical Documentation/Technical File index; ensure correct versioning, approvals, and traceability
- Coordinate and file risk management records (ISO 14971), PMS/PMCF logs, vigilance records, complaints, NCs, and CAPAs
- Perform document formatting, numbering, metadata tagging, cross-referencing, and change control per our QMS (ISO 13485 aligned)
- Prepare audit-ready binders/folders; chase approvers, collect signatures, and close documentation gaps before audits
- Support the BSCI program: collect supplier documents, manage SAQs, schedule audits, log CAPAs, track evidence and due diligence files
- Maintain dashboards and trackers (training matrices, audit findings, CAPA status, supplier compliance KPIs) and generate periodic reports
- Coordinate with Quality, Regulatory, Supply Chain, and Supplier teams to gather inputs and ensure timely submissions
- Train users on document control basics (templates, versioning, filing rules) and uphold records retention requirements
Qualifications:
- Bachelor’s degree in Quality, Regulatory Affairs, Industrial Engineering, Business, Supply Chain, or related field
- 1–3 years of experience in document control, quality, regulatory, or compliance administration; MDR/BSCI exposure is a strong plus
- Familiarity with EU MDR concepts and ISO 13485/ISO 14971 fundamentals
- Understanding of social compliance frameworks (Amfori BSCI or similar) and supplier audit workflows
- Excellent attention to detail, organization, and follow-through; strong written communication
- Proficiency with MS Office/Google Workspace; experience with DMS/QMS tools (e.g., SharePoint, eQMS, Confluence) is an advantage
Compensation:
- 45,000–50,000 PKR per month (based on experience)
Benefits:
- Health and wellness programs
- Opportunities for professional development
- Collaborative work environment
Employment Type:
Location:
- KOTSTEEL (PVT) LTD, Link Wazirabad Road, Dulchikey (Ugoki), Sialkot.
How to Apply:
- Submit your resume/CV and a brief cover letter highlighting relevant MDR document control and/or BSCI experience.
Equal Opportunity:
- We are an equal opportunity employer and value diversity. All employment decisions are based on qualifications, merit, and business needs.
Job Type: Full-time
Pay: From Rs45,000.00 per month
Education:
Experience:
- work: 3 years (Preferred)
Work Location: In person