Quality Assurance Staff (Medical Device)

Standard Biosensor healthcare; Purwakarta; On-site; IDR 111,600,000 - 200,880,000; Full time

Benefits offered by this job

Competitive remuneration

Professional development

Wellbeing initiatives

Job summary

Standard Biosensor healthcare is seeking a Quality Assurance Staff (Medical Device) in Purwakarta, Jawa Barat. The role oversees QA for pharmaceutical and medical products, implementing QA procedures and ensuring regulatory compliance.

Requirements include a bachelor degree in pharmacy or related fields and 2–3 years of QA/QC experience in medical devices or pharmaceuticals. GMP, ISO 13485, ISO 9001 knowledge is essential.

Qualifications

• Bachelor degree as stated in the qualifications.
• Strong knowledge of GMP and ISO standards.
• Experience in QA/QC in medical device or pharma industry.

Responsibilities

• Develop and implement QA procedures to monitor manufacturing and end-product quality.
• Conduct inspections, testing, and audits to identify quality issues.
• Collaborate with production to resolve quality problems and drive continuous improvement.
• Maintain records and documentation to show regulatory compliance.
• Provide training to production staff on quality control best practices.
• Keep up-to-date with regulatory changes and adjust processes accordingly.

Skills

Quality management

GMP knowledge

ISO 13485

ISO 9001

Regulatory know-how

Education

Bachelor Degree in pharmacy, biomedical engineering, or related major

Job description

Quality Assurance Staff (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

• Developing and implementing quality assurance procedures to monitor the manufacturing process and end-product quality
• Conducting regular inspections, testing, and audits to identify and address any quality issues
• Collaborating with the production team to resolve quality-related problems and ensure continuous improvement
• Maintaining detailed records and documentation to demonstrate compliance with industry regulations and standards
• Providing training and guidance to production staff on quality control best practices
• Staying up-to-date with changes in industry regulations and implementing necessary process adjustments

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.

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.