Design Quality Engineer

6+ years professional experience in medical device regulatory , Experience with systems for quality management, product development, and follow-up of procedures.

Experience in medical deviceregulatory Quality systems EU MDR, US FDA 510(k) and closely working R&D, Regulatory Affairs organizations

Expertise in interpreting & implementing various medical device standards and guidance's, such as IEC 60601-1, ISO 10993-1:2018; ISO15223-2021; ISO 14971:2019; EN ISO 13485; ISO 11607-1,2; andEN ISO 11137-1 and MEDDEV 2.7/4

Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.)

Ensures that appropriate Quality Plans are made that include all stages product life cycle ,supports Quality Plan

Validate key design inputs like : Usability, Reliability, Performance, Supportability, Manufacturability, Safety, Security, Privacy, Serviceability, Sustainability etc.

Provides effective oversight of the execution of the Quality Plan, Risk Management activities, and all design related activities during the product/system life cycle

Performs independent technical assessment on product quality performance and post-market product quality analysis

Can Lead quality related problem solving and root cause analysis during design and manufacturing

Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required

Compliance focused

Be able to handle ad-hoc changes in priority/planning and independently.

Be able to think from customer expectation perspective

Be able to work in different teams simultaneously

Communicative & disciplined team worker.

Skills Required

Customer Follow-Ups,Regulatory Reviews,Design Specifications,Design Management,Planning Ability,Product Development,Quality Management,People Management,Design Quality

Location

Pune, India

Desirable Skills

Customer Follow-Ups,Regulatory Reviews,Design Specifications,Design Management,Planning Ability,Product Development,Quality Management,People Management,Design Quality

Designation

Associate