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Quality Engineer II, CA

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Date: Sep 22, 2022

Location: Wayne, NJ, US

Company: Getinge

 

 

At Getinge we have the passion to perform

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

Are you looking for an inspiring career? You just found it.

 

 

Getinge is a global company that designs and manufactures medical devices and life science equipment. We impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.

We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.

We currently have an opening for a Sr. Quality Engineer. This position is responsible for implementation and execution of Quality Engineering II. This position provides leadership and technical support for the quality assurance, process control, and engineering functions.  Leads or is a key contributor to cross functional process improvement and problem solving teams.

 

Job Responsibilities

  • Supports Quality management, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time, and that internal audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule
  • Coordinates technical activities regarding validations: including protocol development, synchronization of interdepartmental activities, evaluation and reporting results
  • Reviews and approves product/process qualification/validation and other change control related documentation.
  • Identifies and leads implementation of new opportunities for improvements to work processes, production, QA testing, and other areas as identified.
  • Investigates product issues by conducting failure investigations, complaint trending, and Product Inquiries.
  • Investigates component issues by conducting failure/root cause investigations and conduct product inquiry reports (PIR), as needed.
  • Communicates, interacts and coordinates quality improvement efforts with Manufacturing, QA, R&D, and engineering management regarding product status, deviations and problems; provides testing and training support to Manufacturing, Engineering and R&D.
  • Supports the Material Review Board by providing or reviewing the disposition of Non-Conforming Material
  • Perform IQ, OQ, PQ and calibration activities as required.

 

Minimum Requirements:   

  • A Bachelor’s degree in Engineering, Science or related field or equivalent is required. A Masters of Science in Engineering, Science or related field is preferred. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.
  • A minimum of 3 years’ experience in quality assurance, quality engineering or related functions or a M.S. plus 1 year experience is required.  Prior experience in a FDA regulated industry or ISO certified organization.

 

Required Knowledge, Skills and Abilities:

  • Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments. 
  • Working knowledge of quality systems is required. Familiarity with analytical software applications is preferred. 
  • Project management and leadership experience is preferred.   Previous experience supervising technicians and conducting and participating in FDA/customer/corporate audits is preferred.
  • Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
  • Ability to use Microsoft Office Products such as Word and Excel or equivalent software applications is preferred.

 

 

About us 

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise ‘Passion for Life’ close to heart. 

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted medtech company.