Quality/Mechanical Engineer

Job Position:

Quality/Mechanical Engineer

Salary:

$75,000 to $80,000 per annum plus Superannuation

Required Qualification:

Degree in Mechanical Engineering or a related field.

2 to 3 years of experience in a quality function within a pharmaceutical, manufacturing, healthcare, or other highly regulated industry.

Knowledge of Good Manufacturing Principles (GMP), Quality Management System requirements (ISO13485, ISO11137), and sterilization processes.

Familiarity with TGA Audits and other regulatory bodies.

Awareness of sterilization, validation, and related microbiology is desirable.

Strong decision-making skills, attention to detail, and effective communication abilities.

Duties and Responsibilities:

Ensure ongoing compliance with legislation and standards related to sterilization and manufacturing operations.

Maintain detailed reports on quality assurance, quality control, and process operations.

Establish standards for installation, modification, testing, inspection, and maintenance according to engineering principles.

Oversee the inspection, calibration, and preventative maintenance of products, components, and equipment.

Drive continuous improvement initiatives and ensure compliance with safety and regulatory standards.

Assist in specification control, monitoring inventory of critical process consumables, and preparing loads for dispatch and validation documentation.