Company Name: Pengiklan Anonim
Location: Cikarang
Posted Date: 14/10/2024 09:22
Salary:
Job Description
Job Title:
Quality Lead
Location:
Cikarang, Bekasi
About Us:
- We are a fast-growing startup on a mission to revolutionize wound care solutions in Indonesia and across Southeast Asia. Our mission is to transform healthcare in Southeast Asia through cutting-edge technology and high-quality products. Join a team driven by innovation, quality, and impact.
Role Overview:
- As the Quality Lead, you will be at the forefront of ensuring that our manufacturing processes not only meet regulatory standards but exceed them. You will lead quality management initiatives, ensuring that our products meet the highest standards of safety, effectiveness, and consistency. If you are a problem-solver who thrives in dynamic environments, enjoys building systems from the ground up, and takes pride in delivering superior results, this role is for you.
Key Responsibilities:
- Develop and manage Quality Management Systems (QMS) in compliance with regulatory standards (e.g., ISO 13485, GMP).
- Monitor production quality, identify inefficiencies, and troubleshoot issues with cross-functional teams to optimize processes and improve quality.
- Lead internal and external audits, ensuring full regulatory compliance.
- Develop a high-performing quality team by fostering a culture of accountability, ownership, and excellence.
- Analyze quality data to inform decision-making and recommend improvements.
- Drive problem-solving initiatives and implement corrective and preventive actions (CAPAs) to ensure product quality.
What We’re Looking For:
- Proven experience in quality operations or quality assurance within a medical device, pharmaceutical, or biotechnology manufacturing environment.
- Strong knowledge of ISO 13485, GMP, and other relevant quality regulations for medical manufacturing.
- Results-driven problem-solver with high attention to detail and quality focus.
- Creative and innovative thinker with a passion for improving operational efficiencies.
- Strong leadership, communication, and team collaboration skills.
- Fluent in Bahasa Indonesia and English.
- Bachelor’s degree in engineering, quality management, or a related field.
What We Offer:
- Impactful role in a dynamic, mission-driven startup.
- Collaborative and innovative work environment where innovation is encouraged, and new ideas are celebrated.
- Competitive salary and career growth opportunities.