Quality Assurance Specialist

4 days ago

Pune, Maharashtra, India beBeeQualityEngineer Full time ₹ 15,44,000 - ₹ 20,16,000
Job Overview

We are seeking an experienced Quality Assurance Engineer to join our team. As a key member of our project team, you will be responsible for ensuring the quality of our medical devices from development to delivery.

Responsibilities
  • Develop and implement design verification and validation plans with the project design lead.
  • Lead the development of Critical to Quality (CTQs), design input and output documents.
  • Manage electronic document control and version control on all project related documents.
  • Ensure adherence to the quality systems and design assurance SOPs.
  • Lead usability, reliability, testing, verification and validation testing internal and local vendors.
  • Provide statistical testing and reliability plans.
  • Provide quality and regulatory compliance guidance as needed to product development or design change project teams.
  • Co-Lead CAPA efforts and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues.
Qualifications and Skills
  • Bachelor's degree in engineering, preferably mechanical engineering.
  • 5-9 years of experience in medical device quality engineering.
  • Professional training and certification in quality management systems including ISO 13485, risk management ISO 14971, design assurance/control, verification and validation.
  • Sound understanding of medical device regulatory requirements for Class II and III medical devices.
  • Project planning resourcing, timelines, quality and budgets.
  • Skilled in implementing quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).
  • CQE certification or similar training and experience preferred.
  • Proficient in project management tools like MS Project.
  • Experience in GD&T.
  • Well versed with statistical analytical techniques and software tools like MATLAB, MINITAB.
About Us

We are committed to delivering high-quality medical devices that meet or exceed customer expectations.

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