Quality Engineer

Summary :

The Quality Engineer is responsible for maintaining, monitoring, and continuously improving key quality system elements to ensure compliance with regulatory standards and support manufacturing excellence. This role plays a critical part in upholding quality standards across ISO 13485 : 2016, ISO 9001 : 2015, AS 9100 Rev D, and FDA CFR Part 820.

Key Responsibilities :

Quality Systems Management

Manage and execute the Internal Audit Program.

Oversee the Non-Conformance (NC) and Corrective and Preventive Action (CAPA) systems.

Maintain and improve the Quality Document Control System.

Prepare and facilitate Management Reviews and Quality performance reports.

Support the Document Control Request process.

Compliance & Regulatory Support

Ensure compliance with ISO 13485, ISO 9001, AS 9100, and FDA CFR Part 820.

Lead and participate in external audits.

Collaborate with QE / QC and Validation teams to ensure integrated quality system implementation.

Data Analysis & Reporting

Monitor and analyze quality metrics such as non-conformances, scrap, yield, and repeat NRFT (Not Right First Time) issues.

Develop and present management-level reporting on quality performance.

Project & Continuous Improvement

Lead and complete assigned Quality System Improvement Projects.

Support cross-functional quality improvement initiatives.

General Responsibilities

Promote a culture of quality and compliance across departments.

Maintain work areas in accordance with GMP standards.

• Report maintenance and Health & Safety issues promptly.

Adhere to company Health & Safety policies, including PPE requirements.

Required Qualifications :

Honours Degree in Quality, Mechanical, Manufacturing, or Production Engineering (or related field).

Minimum 5 years’ experience in quality assurance within a production environment.

Proven experience with GMP and ISO 13485.

Familiarity with FDA CFR Part 820 and ISO 9001 is desirable.

Proficient in MS Office and Quality Enterprise Systems.

Skilled in formal problem-solving tools (, 5 Whys, Fishbone, A3).

Pay Details : $100, to $120, per year

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