Job Description

P3-11554
Performs quality assurance activities to ensure compliance with applicable medical device
regulatory requirements. Contributes to the completion of specific programs and projects
usually under the direction of a project leader. Good understanding and frequent application of
quality assurance principles, design control concepts, industry practices, and standards. Works
under general direction while independently determining and developing approaches to
solutions. Frequent inter-organization and limited outside customer contacts.

P3-11554

Educational Background: Bachelor’s degree in mechanical engineering, biomedical engineering or related engineering
discipline.

Professional Experience:
0-5 years of relevant experience

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.

Knowledge and Skills
a. Knowledge
 Good working knowledge of medical device regulations and practices (ISO
13485, FDA QSR, etc.).
 Practical and demonstrated experience of Quality or Reliability engineering,
risk analysis, product development and verification/validation testing in the
medical device industry.
 Demonstrated hands-on experience with Design Control procedures.
 Experience in a Phase-Gate development process.
 Experience in directly applying statistical methods for quality improvement.
 Good knowledge and understanding of process development, total quality
tools, and continual improvement approaches.
b. Skills
 Good technical writing skills.
 Familiarity with statistical methods and analysis and/or Minitab software.
 Team player with excellent interpersonal and communication skills.

Desired / Additional Skills & Knowledge (Not essential to the job but will be an
advantage to possess)
 Familiarity with Six Sigma methodology.
 Experience in high volume manufacturing and assembly processes, particularly those of
plastic injection molded parts and assemblies.
 Disciplined and well-organized in documentation (plans, requirements, drawings, design
reviews, and test methods).

Strong critical thinking, analytical, and problem-solving skills.

Any additional Information (Specially if needed for Quality or legal purposes)
• Certified Quality Engineer (CQE)
• Certified Six Sigma Green Belt (SSGB) and/ or Six Sigma Black Belt (SSBB)

Required Skills

Optional Skills

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift