Senior Quality Assurance Engineer

6 days ago


Wayne, New Jersey, United States Getinge Full time
About the Role

We are seeking a highly skilled and experienced Senior Quality Assurance Engineer to join our team at Getinge. This role will be responsible for ensuring the effective establishment and maintenance of quality systems, supporting quality planning, and coordinating technical activities related to validations.

Key Responsibilities
  • Develop and implement quality plans and gap assessments to ensure compliance with regulatory requirements.
  • Support quality management functions, including corrective and preventive actions, non-conforming material review, and supplier management.
  • Coordinate and complete tasks and documentation required for externally supplied component qualifications (First Article Inspections).
  • Conduct failure investigations, complaint trending, and product inquiries to identify root causes of issues.
  • Communicate and coordinate quality improvement efforts with manufacturing, QA, R&D, and engineering management.
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree in Engineering, Science, or equivalent; a Master's degree is preferred.
  • A minimum of five years' experience in quality assurance, quality engineering, or related functions.
  • Demonstrated proficiency in statistical analysis, problem-solving, and communication skills.
  • Working knowledge of quality systems and analytical software applications.
  • Project management and leadership experience, with previous experience supervising technicians and conducting audits.
About Us

Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. Our offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science. We employ over 12,000 people worldwide and sell our products in more than 135 countries.

With a salary range of $100k-$120k + bonus targeted at 10% depending on overall company performance, this is an exciting opportunity to join a global leader in the medical device industry.



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