Quality Engineer

Designation: Engineer

Location: USA

Qualification: Bachelor’s Degree


  • Improve the manufacturing process specifications for the production of new generation heart valves.
  • Collaborate with engineering and manufacturing functions to ensure quality standards are in place.    
  • Implement periodic reviews and updates to the company procedures (GSOP) to align with the current standards.
  • Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Design or specify testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis.
  • Author and execute TMV’s on the newly created process production specifications.
  • Develop Inspection Method and Test Method Validation (TMV) Protocols and Reports.
  • Write and oversee execution of Test Method Validation and perform attribute and variable test method validations (TMV).
  • Assure compliance of test methods with SOPs and, where necessary, revise/originate SOPs for methods unique to product.
  • Perform Test Method Validation (TMV) for equipment/processes utilizing statistics & gage R&R for analysis.
  • Perform GAP Analysis and develop corresponding Remediation plan.
  • Work hand in hand with R&D labs/ manufacturing engineers to answer questions related to application and use of quality tools viz. SPC, capability analysis.

Bachelor’s Degree required in Pharmaceutical Science.

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