QA & Compliance Officer

Location: Sehat Medical Devices Pvt. Ltd, Sundar Industrial Estate, Lahore (on-site)

Department: Quality Assurance & Regulatory Compliance

Reports To: Quality Assurance Manager

Position Overview:

The QA & Compliance Officer will assist in ensuring that all operations at Sehat Medical Devices meet international quality and regulatory standards for medical device manufacturing. The role focuses on maintaining robust documentation, compliance reporting, and process validation systems within an ISO-certified and GMP-regulated environment.

This is an ideal opportunity for fresh graduates who are eager to begin a career in medical device quality and compliance

Key Responsibilities:

· Quality System Management:

o Assist in maintaining and improving the Quality Management System in line with international medical device standards.

o Support document control activities — creation, issuance, revision, and archival of controlled records.

o Help coordinate internal audits, management reviews, and quality improvement initiatives.

o Participate in the preparation and upkeep of product technical files, manufacturing records, and validation protocols.

· Compliance & Regulatory Support:

o Develop structured documentation to support product conformity, safety evaluation, and registration activities.

o Maintain compliance records for all certifications and regulatory submissions.

o Assist in preparing and updating product master files, design dossiers, and related technical data.

o Coordinate with external auditors and regulatory inspectors for site inspections, renewals, and compliance reviews.

o Monitor process adherence to ensure continued qualification of products for domestic and international tenders and institutional programs.

· Manufacturing Quality Oversight:

o Conduct in-process quality checks and assist in product release documentation.

o Record deviations and assist in root cause analysis and corrective/preventive actions (CAPA)

o Collaborate with Production and QC teams to maintain consistent quality and traceability throughout the manufacturing cycle.

· Training & System Development:

o Participate in developing new templates, forms, and controlled documents to enhance system traceability and compliance.

o Attend training sessions on quality management, data integrity, and international conformity documentation practices.

o Support the development of structured product files required for market authorization and qualification programs.

Qualifications & Skills:

Education: Pharm-D, BSc/MSc in Biomedical Engineering, Industrial Engineering, Biotechnology, Chemistry, or a related field.

Experience: Fresh graduates or up to 1 year of experience in QA, QC, or regulatory compliance (medical devices or pharmaceuticals preferred).

Knowledge Areas: (Benificial to have)

· Understanding of quality systems (ISO 13485 / ISO 9001).

· Basic knowledge of product conformity documentation, validation, and risk management.

· Familiarity with principles of manufacturing process qualification and technical file compilation.

Skills:

· Excellent documentation, recordkeeping, and analytical ability.

· Strong communication and reporting skills.

· Proficiency in Microsoft Office (Word, Excel, PowerPoint).

· Detail-oriented, organized, and disciplined approach to compliance work.

Interested candidates may send their CVs to hr@sehat.ltd

Job Type: Full-time

Work Location: In person