Design Quality Engineer

Bangalore, Karnataka
Permanent
Full-time

7 days ago

It's fun to work in a company where people truly BELIEVE in what they are doing!We're committed to bringing passion and customer focus to the business.Position Objective:The Design Quality Engineer will be instrumental in driving the quality assurance aspects of product design & development, from concept through to market release. This role requires a seasoned professional with a deep understanding of medical device regulations, standards, and quality management systems (QMS). A successful candidate will collaborate closely with cross-functional teams to ensure that design controls, risk management, and validation activities are effectively executed and documented in accordance with regulatory requirements.Responsibilities:

Lead the quality engineering activities in product development projects, ensuring compliance with ISO 13485, FDA QSR/QMSR, EU MDR and other applicable regulations and standards.
Facilitate the application of design controls, including design and development planning, input, output, review, verification, validation, and transfer activities.
Ensure that development activities follow design control requirements (demonstrated via Traceability Matrix), product is tested per applicable standards, ER/GSPR are met per the MDD/MDR, and product is properly transferred to manufacturing per applicable specifications.
Champion risk management activities according to ISO 14971, ensuring risks are identified, evaluated, and mitigated throughout the product lifecycle.
Collaborate with R&D, regulatory affairs, manufacturing, and other departments to ensure quality and regulatory requirements are integrated into the product development process.
Author, review and/or approve technical documentation, including, but not limited to, design specifications, DFMEA, PFMEA, UFMEA, verification & validation protocols/reports, product labelling, equipment qualifications, and design changes, ensuring they meet regulatory and quality requirements.
Lead complex root cause analysis and problem-solving activities related to product design & development and risk management.
Support continuous improvement initiatives by identifying opportunities to enhance the QMS, particularly in areas related to design & development and risk management.
Participate in internal and external audits and lead the resolution of any findings related to product design and development.
Serve as a subject matter expert on Quality-related matters (e.g. risk management, human factors, statistical analysis) in their application to design controls, and provide guidance and training to others, as necessary.
Provide expert interpretation of current and emerging regulations, standards and guidance impacting the design & development and risk management process.
Assist in the preparation of submissions for regulatory agencies.
Performs other duties assigned as needed.

Critical Success factors:

In-depth knowledge of FDA QSR/QMSR, MDSAP, EU MDD/MDR, ISO 13485, ISO 14971, ISO 62366, ISO 15223, and other relevant standards and regulations highly preferred.
ASQ Certification (CQE, CRE, or similar) is highly desirable.

Qualifications:

Bachelor’s degree in Biomedical, Mechanical, Industrial, Materials or related Engineering discipline.

Experience:

Minimum of 3 years of experience in the medical device industry, with a strong focus on quality engineering and regulatory compliance.

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!Not the right fit? Let us know you're interested in a future opportunity by clicking Introduce Yourself in the top-right corner of the page or create an account to set up email alerts as new job postings become available that meet your interest!

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