Quality Assurance Staff (Validation - Medical Device)

Standard Biosensor healthcare; Purwakarta; On-site; IDR 78,120,000 - 133,920,000; Full time

Benefits offered by this job

Competitive remuneration

Professional development opportunities

Wellbeing initiatives

Supportive work environment

Job summary

Standard Biosensor healthcare is seeking a Quality Assurance Staff (Validation - Medical Device) based in Purwakarta, Jawa Barat. You will oversee the QA process for our medical devices and ensure compliance with validated protocols and regulatory standards.

Key responsibilities include preparing validation schedules, IQ/OQ/PQ activities, and reviewing validation data and reports. The role requires a Bachelor's in pharmacy or related field and 2–3 years' QA/quality control experience in medical

Qualifications

• Bachelor's degree in pharmacy, biomedical engineering, or a related field.
• 2–3 years of QA/quality control experience in medical devices or pharma.
• Strong knowledge of GMP, ISO 13485/9001, CPAKB, and regulatory requirements.

Responsibilities

• Prepare validation schedules based on priority and risk.
• Establish validation strategies based on risk assessment.
• Ensure validation activities comply with approved protocols.
• Prepare or review Process Validation Protocols.
• Conduct IQ/OQ/PQ activities as required.
• Collect and evaluate validation data.
• Prepare validation reports after completion.
• Assess need for revalidation after changes to processes or equipment.

Skills

Quality assurance

Validation knowledge

GMP ISO knowledge

Analytical thinking

Problem solving

Attention to detail

Communication

Education

Bachelor Degree in pharmacy, biomedical engineering, or related major

Job description

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

• competitive remuneration
• opportunities for professional development
• a range of employee wellbeing initiatives to promote a healthy work-life balance
• supportive and rewarding work environment

PT Standard Biosensor Indonesia is a leading importer & distribution company of medical devices, providing molecular research reagent and instrument also molecular diagnostics kit of PCR, Rapid Test and POCT for hospital, clinics and laboratory needs with up-to-date standard, competitive price and best quality. Our company represents and distributes all product of SD Biosensor Inc. and Bioneer Corporation (South Korea). The products that we offer are high quality imported products which has met the international standardization and has been widely used in well-known hospitals, clinics and laboratories in Indonesia.

PT Standard Biosensor Indonesia is a leading importer & distribution company of medical devices, providing molecular research reagent and instrument also molecular diagnostics kit of PCR, Rapid Test and POCT for hospital, clinics and laboratory needs with up-to-date standard, competitive price and best quality. Our company represents and distributes all product of SD Biosensor Inc. and Bioneer Corporation (South Korea). The products that we offer are high quality imported products which has met the international standardization and has been widely used in well-known hospitals, clinics and laboratories in Indonesia.