Senior Design Quality Engineer

Senior Engineer- Design Quality

Work Flexibility: Hybrid

What you will do:

• Review quality assurance documentation to support mainly product sustenance and regulatory submissions or new product development related to line extensions/custom made devices and product life cycle management.

• Support quality system maintenance and effectiveness by identifying and correcting deficiencies in procedures and practices.

• Execute risk management activities for NPI and Sustenance projects - Ensure that risk assessments are conducted in accordance with EUMDR requirements.

• Participate in design reviews by identifying risks associated with the product used and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development or legacy care process.

• Taking care of timely and quality deliverables for assigned projects.

• Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.

• Work closely with R&D, Clinical Affairs, Post Market, and other departments to integrate EUMDR compliance into product development processes.

 

What you need:

Required Skills:

• B.Tech in Mechanical Engineering / Biomedical. Experience: 3-6 years

• 2+ years’ experience in Design Quality Assurance (medical devices) or new product development

• In-depth knowledge of EUMDR requirements and other relevant regulations. Relevant certifications in regulatory affairs or quality management may be beneficial.

• Excellent understanding of Quality Management Systems. (ISO 13485, 21 CRF 820).Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.

• Knowledge of EU MDR changes, ISO 14971, IEC 62366, Quality Concepts (e.g. CAPA, Audits, Statistics).

Preferred Skills:

• AQE should drive coordination with different departments (such a R&D, Post Market Regulatory, Clinical) to ensure the resulting part/product/process is safe, compliant, and effective.

• Demonstrated ability to advocate for product excellence and quality.

• Strong experience in establishing world class risk methodologies for complex systems based upon existing corporate/divisional approaches.

• Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above.Insert detailed job description here.

Travel Percentage: 20%

Experience Level

Senior Level