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Technical Manager
PROVACU LABORATORY INSTRUMENTS INDUSTRY LLC
Umm Al Quwain, UAE
Full Time
Manager
Onsite
3 days ago
GMPISO 13485Medical Device ManufacturingQuality AssuranceRegulatory AffairsProcess Validation
Free
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GMPISO 13485Medical Device Manufacturing
About the Role
PROVACU LABORATORY INSTRUMENTS INDUSTRY LLC is hiring a Technical Manager to lead technical, quality, regulatory, and manufacturing compliance for a new blood collection tube facility in Umm Al Quwain.
Key Skills for This Role
GMPISO 13485Medical Device ManufacturingQuality AssuranceRegulatory AffairsProcess Validation
Responsibilities
- Manage and oversee all technical activities related to the manufacturing of blood collection tubes and sample collection containers
- Ensure that manufacturing processes, products, equipment, and documentation comply with GMP, ISO 13485, and applicable UAE medical device regulations
- Develop, review, approve, and implement standard operating procedures, technical procedures, quality protocols, validation documents, and manufacturing instructions
- Oversee raw material, in process, and finished product quality requirements
- Ensure appropriate testing of medical devices, including sterility, leakage, vacuum, dimensional, performance, and packaging integrity testing
- Review and approve product specifications, technical drawings, bills of materials, manufacturing records, testing reports, and product release documentation
- Establish and maintain technical files and documentation required for medical device registration and regulatory submissions
- Coordinate with regulatory authorities, certification bodies, consultants, suppliers, manufacturers, and internal departments
- Lead equipment qualification, process validation, test method validation, cleaning validation, and facility qualification activities
- Ensure that laboratory and production equipment is properly maintained, calibrated, qualified, and documented
- Investigate deviations, nonconformities, product complaints, and quality issues
- Implement corrective and preventive actions and monitor their effectiveness
Requirements
- Bachelor’s or master’s degree in Pharmacy, Biomedical Engineering, Medical Engineering, or another relevant medical or scientific discipline
- Previous experience in the medical device, pharmaceutical, healthcare, or medical manufacturing industry
- Strong knowledge of Good Manufacturing Practices (GMP)
- Practical knowledge of ISO 13485 quality management system requirements
- Experience in medical device manufacturing, quality assurance, quality control, regulatory affairs, or technical operations
- Knowledge of medical device technical documentation, product registration, validation, qualification, risk management, and regulatory compliance
- Experience managing deviations, change controls, nonconformities, complaints, and CAPA
- Strong technical writing, documentation, analytical, leadership, and problem solving skills
- Ability to communicate effectively with regulatory authorities, suppliers, auditors, and internal teams
- Experience working in a GMP regulated environment is essential
Full Job Posting
Job description
- PROVACU LABORATORY INSTRUMENTS INDUSTRY LLC – We Are Hiring!
- Location: Umm Al Quwain, UAE
- Position: Technical Manager – Medical Devices
- Employment Type: Full time / Contract
About the Company
- PROVACU LABORATORY INSTRUMENTS INDUSTRY LLC is establishing a new manufacturing facility for blood collection tubes and sample collection containers in Umm Al Quwain.
- We are seeking a qualified and experienced Technical Manager to lead the technical, quality, regulatory, and manufacturing compliance activities of the facility.
Key Responsibilities
- Manage and oversee all technical activities related to the manufacturing of blood collection tubes and sample collection containers.
- Ensure that manufacturing processes, products, equipment, and documentation comply with GMP, ISO 13485, and applicable UAE medical device regulations.
- Develop, review, approve, and implement standard operating procedures, technical procedures, quality protocols, validation documents, and manufacturing instructions.
- Oversee raw material, in process, and finished product quality requirements.
- Ensure appropriate testing of medical devices, including sterility, leakage, vacuum, dimensional, performance, and packaging integrity testing.
- Review and approve product specifications, technical drawings, bills of materials, manufacturing records, testing reports, and product release documentation.
- Establish and maintain technical files and documentation required for medical device registration and regulatory submissions.
- Coordinate with regulatory authorities, certification bodies, consultants, suppliers, manufacturers, and internal departments.
- Lead equipment qualification, process validation, test method validation, cleaning validation, and facility qualification activities.
- Ensure that laboratory and production equipment is properly maintained, calibrated, qualified, and documented.
- Investigate deviations, nonconformities, product complaints, and quality issues.
- Implement corrective and preventive actions and monitor their effectiveness.
Requirements
- Bachelor’s or master’s degree in Pharmacy, Biomedical Engineering, Medical Engineering, or another relevant medical or scientific discipline.
- Previous experience in the medical device, pharmaceutical, healthcare, or medical manufacturing industry.
- Strong knowledge of Good Manufacturing Practices (GMP).
- Practical knowledge of ISO 13485 quality management system requirements.
- Experience in medical device manufacturing, quality assurance, quality control, regulatory affairs, or technical operations.
- Knowledge of medical device technical documentation, product registration, validation, qualification, risk management, and regulatory compliance.
- Familiarity with sterility requirements, cleanroom operations, contamination control, and laboratory testing is preferred.
- Experience managing deviations, change controls, nonconformities, complaints, and CAPA.
- Strong technical writing, documentation, analytical, leadership, and problem solving skills.
- Ability to communicate effectively with regulatory authorities, suppliers, auditors, and internal teams.
- Experience working in a GMP regulated environment is essential.
- Previous experience with blood collection tubes, sample containers, sterile medical devices, or in vitro diagnostic products will be an advantage.
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