Quality Assurance Staff (Validation - Medical Device)

About the role

As a Quality Assurance Staff (Medical Device) at Standard Biosensor healthcare', you will play a crucial role in ensuring the quality and safety of the company's medical devices. This full-time position is based in Purwakarta, Jawa Barat, and will involve overseeing the entire quality assurance process for the organisation's pharmaceutical and medical products.

What you'll be doing

• Prepare validation and qualification schedules based on priority and risk assessment.

• Establish validation strategies based on risk assessment.

• Ensure all validation activities are conducted in accordance with approved protocols.

• Prepare and/or review Process Validation Protocols.

• Conduct IQ/OQ/PQ activities as required.

• Collect and evaluate validation data.

• Prepare Validation Reports upon completion of validation activities.

• Assess the need for revalidation when there are changes to processes, equipment, materials, facilities, or critical parameters.

What we're looking for

• Bachelor Degree in pharmacy, biomedical engineering, or related major

• Minimum 2-3 years of experience in a quality assurance or control role within the medical device or pharmaceutical industry

• Strong knowledge of quality management systems, Good Manufacturing Practices (GMP), ISO 13485, ISO 9001, CPAKB, and relevant regulatory requirements

• Excellent problem-solving, analytical, and critical thinking skills

• Meticulous attention to detail and a commitment to ensuring the highest standards of quality

• Effective communication and interpersonal skills to liaise with cross-functional teams

What we offer

At Standard Biosensor healthcare', we are committed to providing a supportive and rewarding work environment for our employees. You can look forward to competitive remuneration, opportunities for professional development, and a range of employee wellbeing initiatives to promote a healthy work-life balance. If you are passionate about quality assurance and making a difference in the healthcare industry, we encourage you to apply for this exciting role.

Apply now to join our dynamic team at Standard Biosensor healthcare'.