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).

Must be a high school graduate. Further training in child care and development from some registered institution (eg. ACNS ). Proven child care experience with references. First Aid and CPR certification. Safety certification. A valid driving license and a safe driving record.

Education

None

Key Skills

Anti Money Laundering,Active Directory,Computer Software,ABAP,ESL Teaching,Accident Investigation

Experience : years

Vacancy : 1

Monthly Salary Salary : 100000 - 500000