Deskripsi Pekerjaan
About Dexcom
Dexcom is a global leader in continuous glucose monitoring systems, dedicated to empowering people with diabetes through innovative technology. At our state-of-the-art facility in Batu Kawan, Penang, we are committed to quality and excellence.
Role Overview
We are seeking a highly motivated and experienced Senior Quality Assurance Engineer to join our team. In this critical role, you will be a key contributor supporting and collaborating across regulatory and IT compliance areas. You will ensure that our software products and documentation meet the highest standards of quality and comply with global regulatory requirements.
Key Responsibilities
- Develop and maintain quality documentation including standard operating procedures, work instructions, and validation protocols.
- Perform software quality assurance activities including test planning, execution, and reporting to ensure product reliability.
- Ensure compliance with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and MDR for software and documentation.
- Collaborate with engineering and regulatory teams to identify and resolve quality issues throughout the product lifecycle.
- Conduct internal audits and support external regulatory audits by preparing documentation and evidence.
- Drive continuous improvement initiatives within the quality management system.
- Participate in risk management activities according to ISO 14971.
- Review and approve change orders, deviations, and CAPAs to ensure effective quality control.
Qualifications
- Bachelor’s degree in Engineering, Computer Science, or a related discipline.
- Minimum 5 years of experience in quality assurance within the medical device or other regulated industry.
- Strong knowledge of software development lifecycle, software validation, and testing methodologies.
- Experience with quality management systems (QMS), document control, and electronic QMS tools.
- Excellent written and verbal communication skills, with attention to detail.
- Familiarity with standards including ISO 13485, IEC 62304, FDA 21 CFR Part 820, and ISO 14971.
- Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or similar certification is a plus.
- Ability to work independently and collaboratively in a fast-paced environment.
Why Join Dexcom?
At Dexcom, you will work with a talented team dedicated to making a difference in the lives of millions. We offer competitive compensation, comprehensive benefits, and opportunities for professional growth. If you are passionate about quality and compliance, we want to hear from you.
Tanggung Jawab
- Develop and maintain quality documentation including standard operating procedures, work instructions, and validation protocols.
- Perform software quality assurance activities including test planning, execution, and reporting to ensure product reliability.
- Ensure compliance with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and MDR for software and documentation.
- Collaborate with engineering and regulatory teams to identify and resolve quality issues throughout the product lifecycle.
- Conduct internal audits and support external regulatory audits by preparing documentation and evidence.
- Drive continuous improvement initiatives within the quality management system.
- Participate in risk management activities according to ISO 14971.
- Review and approve change orders, deviations, and CAPAs to ensure effective quality control.
Kualifikasi
- Bachelor’s degree in Engineering, Computer Science, or a related discipline.
- Minimum 5 years of experience in quality assurance within the medical device or other regulated industry.
- Strong knowledge of software development lifecycle, software validation, and testing methodologies.
- Experience with quality management systems (QMS), document control, and electronic QMS tools.
- Excellent written and verbal communication skills, with attention to detail.
- Familiarity with standards including ISO 13485, IEC 62304, FDA 21 CFR Part 820, and ISO 14971.
- Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or similar certification is a plus.
- Ability to work independently and collaboratively in a fast-paced environment.