Quality Assurance Staff (Medical Device)

Standard Biosensor healthcare; Purwakarta; On-site; IDR 100.000.000 - 200.000.000; Full time

Job summary

A leading medical device company in Purwakarta is seeking a Quality Assurance Staff. In this full-time role, you will ensure the quality and safety of medical devices through the implementation of quality assurance procedures and collaboration with production teams. The ideal candidate has 2-3 years of experience in quality assurance within the medical device industry and a Bachelor's degree in a related field. Competitive remuneration and professional development opportunities are offered.

Benefits

Competitive remuneration

Opportunities for professional development

Employee wellbeing initiatives

Qualifications

• Minimum 2-3 years of experience in quality assurance or control role in medical device or pharmaceutical industry.
• Strong knowledge of quality management systems, GMP, ISO 13485, CPAKB.
• Commitment to highest standards of quality.

Responsibilities

• Develop and implement quality assurance procedures.
• Conduct regular inspections and audits to address quality issues.
• Collaborate with production to resolve quality-related problems.

Skills

Problem-solving

Analytical skills

Attention to detail

Effective communication

Education

Bachelor's 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 involves 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's Degree in pharmacy, biomedical engineering, or a 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, 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.

Company Overview: Pharmaceuticals, Biotechnology & Medical, 11-50 employees

PT Standard Biosensor Indonesia is a leading importer & distributor of medical devices, providing molecular research reagents, instruments, and molecular diagnostics kits such as PCR, Rapid Tests, and POCT for hospitals, clinics, and laboratories. Our products meet international standards, are competitively priced, and of the highest quality. We represent and distribute products from SD Biosensor Inc. and Bioneer Corporation (South Korea), widely used in reputable hospitals, clinics, and laboratories across Indonesia.