Cepheid, a Danaher company, is a global leader in molecular diagnostics, dedicated to improving healthcare through fast and accurate diagnostic testing. Their innovative solutions address complex health challenges, ensuring better patient outcomes worldwide.
As part of Danaher’s Diagnostics platform, Cepheid collaborates with six other Danaher Diagnostics companies to deliver cutting-edge diagnostic tools. Danaher’s Business System (DBS) drives continuous improvement, operational excellence, and career growth for its 69,000+ associates worldwide.
Job Description
Cepheid is hiring a Quality Control Analyst I in Bengaluru to join their Quality Organization. This role reports to the Quality Control Lead and ensures compliance with MDR 2017, European regulations, and ISO 13485 standards.
Key Responsibilities:
✔ Conduct routine & non-routine analysis of raw materials, in-process, and finished products.
✔ Supervise testing & analysis of diagnostic reagents & kits.
✔ Perform inspections of incoming, in-process, and finished goods.
✔ Calibrate & maintain lab equipment as per regulatory requirements.
✔ Support method validation, deviation reports, and SOP revisions.
✔ Ensure lab safety, cleanliness, and compliance with GxP regulations.
✔ Review batch records, QC test results, and product release.
✔ Assist in internal audits, CAPA, and non-conformance investigations.
Education & Experience:
- Master’s degree in Biochemistry, Molecular Biology, Microbiology, or related field.
- 3+ years in Quality Control, with 2+ years in IVD (In Vitro Diagnostics).
- Experience with ISO 13485, MDR, and medical device QMS is a plus.
Required Skills:
- Hands-on IVD product testing experience.
- Knowledge of GxP, ISO 13485, and medical device regulations.
- Strong attention to detail, multitasking, and communication skills.
- Proficiency in Microsoft Word & Excel.
- Ability to work flexible shifts (including weekends) if required.
Preferred Qualifications:
- Experience in medical device quality systems (MDR, ISO 13485).
- Knowledge of continuous improvement & lean manufacturing.
- Familiarity with facility QMS certification processes.
Why Join Cepheid?
✅ Global Impact: Work on life-saving diagnostic solutions.
✅ Career Growth: Danaher’s DBS framework fosters professional development.
✅ Inclusive Culture: Danaher promotes diversity & equal opportunity.
✅ Innovation-Driven: Be part of a team shaping the future of diagnostics.
