Medical Device QA & Validation Specialist

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

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