Deskripsi Pekerjaan
Join Standard Biosensor Indonesia as a Quality Assurance Staff (Medical Device)!
Are you passionate about ensuring the highest standards of quality and safety in medical devices? Standard Biosensor Indonesia, a leader in innovative biosensor technology, is seeking a dedicated Quality Assurance Staff to join our dynamic team in Purwakarta, West Java. This is an exceptional opportunity for a detail-oriented professional to contribute significantly to products that enhance patient care and outcomes.
At Standard Biosensor Indonesia, we are committed to excellence, continuous improvement, and fostering an environment where our employees can thrive. As a Quality Assurance Staff member, you will play a critical role in upholding our stringent quality management system, ensuring compliance with global medical device regulations, and supporting the entire product lifecycle from development to post-market surveillance. We offer a stimulating work environment, excellent career growth prospects, and a commitment to work-life balance.
If you have a keen eye for detail, a strong understanding of quality principles, and a desire to make a tangible impact on healthcare, we invite you to apply. Join us and be a part of a team that’s making a difference!
Tanggung Jawab
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 13485 and local regulatory requirements for medical devices.
- Conduct internal and external audits (supplier audits) to ensure compliance with established procedures and regulatory standards.
- Manage document control processes, including review and approval of quality documentation such as SOPs, work instructions, and records.
- Investigate non-conformances, customer complaints, and deviations, leading root cause analysis and implementing effective Corrective and Preventive Actions (CAPA).
- Participate in risk management activities for medical devices, ensuring proper identification, assessment, and control of risks.
- Support product release activities by reviewing batch records and ensuring all quality parameters are met.
- Provide quality training and guidance to other departments to foster a culture of quality throughout the organization.
- Collaborate with R&D, Production, and Regulatory Affairs teams to integrate quality requirements into all stages of the product lifecycle.
Kualifikasi
- Bachelor's degree in Engineering (Biomedical, Electrical, Mechanical, Industrial), Pharmacy, Chemistry, or a related scientific field.
- Minimum of 1-3 years of experience in Quality Assurance or Quality Control, preferably within the medical device, pharmaceutical, or biotechnology industry.
- Strong understanding and practical experience with ISO 13485 standard and Good Manufacturing Practices (GMP).
- Familiarity with local medical device regulations (e.g., Kemenkes RI) is highly advantageous.
- Proven ability to perform root cause analysis and implement effective CAPA.
- Excellent analytical, problem-solving, and decision-making skills with keen attention to detail.
- Strong communication (written and verbal) and interpersonal skills, with the ability to collaborate effectively across departments.
- Proficiency in English is a plus.
- Ability to work independently and as part of a team in a fast-paced environment.