Biomedical Engineering Jobs | BD is Hiring Quality Engineer | Apply Now
Looking to kickstart your biomedical engineering career? This QA Jobs opportunity in Bengaluru offers hands-on experience in medical device quality assurance, design control, and risk management. Join a dynamic team and build your BD career in a fast-growing medical device environment.
- Job Position: Quality Engineer
- Location: Onsite, Bengaluru, Karnataka
- Job ID: R-534456
About the Institute
The hiring company is a leading medical device organization based in Bengaluru, Karnataka. Renowned for its commitment to quality and innovation, it provides professionals with opportunities to work on cutting-edge products while maintaining compliance with global standards like ISO 13485 and FDA QSR.
Job Responsibilities
- Participates in design control activities of medical device products. Ensures proper design and development control and its documentation as per ISO 13485/ FDA QSR Quality System.
- Leads or supports Risk Management in accordance with ISO14971.
- Contributes as a team member on development projects carrying out assigned quality assurance responsibilities in a timely, diligent, and professional manner.
- Creates, implements changes to, and maintains controlled documents as needed (e.g., SOPs, Specifications, Methods, etc.) to ensure strict compliance of R&D functional operation with ISO 13485/ 21 CFR 820 Quality System/ EN requirements.
- Supports continuous improvement of the Quality Systems.
- Applies Statistical tools to support product development process.
- Provides QS knowledge to organization as needed. Administers appropriate training as needed.
- Participates in the ongoing operations of QA/QS activities.
Qualification
Bachelor’s degree in biomedical engineering or related engineering discipline.
Professional Experience
0-5 years of relevant experience
Skills Required
- Good understanding of ISO 13485, FDA QSR, and medical device regulations.
- Experience in design control, phase-gate development, verification/validation testing.
- Knowledge of statistical methods (Minitab preferred).
- Strong technical writing, analytical, and problem-solving skills.
- Team player with excellent communication.
- Bonus: Six Sigma Green/Black Belt certification, experience in high-volume manufacturing.
This is an excellent opportunity for candidates seeking biomedical engineering jobs to grow their BD career in QA. If you’re passionate about medical devices and quality assurance, this QA Jobs opening in Bengaluru is perfect for you. Take the next step in your professional journey and contribute to innovative healthcare solutions.
