Quality Assurance ( Medical & equipment )

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Position: Quality Assurance (QA) Manager – Surgical & Medical Gloves

Department: Quality Assurance

Reports To: Director of Quality / Plant Manager

Location: [Insert Location]

Employment Type: Full-Time

Job Purpose:

To lead and manage the quality assurance department, ensuring that all surgical and medical gloves produced meet regulatory, quality, and safety standards, and are in full compliance with ISO, FDA, ASTM, and other applicable standards.

Key Responsibilities:

Quality Management System (QMS):

Develop, implement, and maintain an effective QMS compliant with ISO 13485, ISO 9001, FDA 21 CFR Part 820, and other regulatory standards applicable to medical device manufacturing.

Regulatory Compliance:

Ensure that products meet all regulatory requirements including FDA, CE marking, ASTM standards, and other local/international certifications.

Process Control & Improvement:

Monitor production processes to ensure product quality and consistency. Lead process validation, CAPA, risk management, and root cause analysis efforts.

Inspection and Testing Oversight:

Supervise incoming, in-process, and final product inspection and testing activities. Ensure all gloves meet defined specifications for physical, chemical, and microbiological attributes.

Internal and External Audits:

Plan and lead internal audits; coordinate with external auditors and regulatory authorities during inspections and audits. Address non-conformities with corrective/preventive actions.

Documentation and Reporting:

Maintain accurate QA documentation, including batch records, test reports, deviation reports, and audit findings. Generate monthly quality performance reports for senior management.

Team Leadership:

Lead, mentor, and train QA staff to ensure continuous development and adherence to quality standards and procedures.

Customer Complaint Handling:

Investigate and resolve quality-related customer complaints. Implement improvements to prevent recurrence.

Supplier Quality Assurance:

Evaluate and audit suppliers of raw materials to ensure incoming goods meet quality requirements.

Qualifications and Skills:

Bachelor’s degree in Chemistry, Microbiology, Biomedical Engineering, or a related field. Master’s preferred.

Minimum 5–8 years of experience in quality assurance within a medical device or glove manufacturing industry.

In-depth knowledge of international regulatory standards (ISO 13485, FDA, ASTM, EN).

Strong analytical, problem-solving, and leadership skills.

Excellent communication and interpersonal skills.

Proficient in MS Office, QMS software, and statistical tools (e.g., Minitab).