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Sr. Quality Engineer (CAPA) - Wayne, NJ

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Date: Nov 30, 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 will work across both the Cardiac Assist (CA) and Cardiac Surgery/Vascular Intervention (CS/VI) business areas of the New Jersey site. This role provides technical support for Quality Assurance with an emphasis on the Corrective and Preventive Action (CAPA) process.  The ideal candidate will effectively:

•Motivate and drive cross-functional problem solving teams to support consistency and timeliness of CAPA activities and associated documentation.

•Support CAPA activities to ensure performance in compliance with applicable regulatory and procedural requirements.

•Support CAPA Coordinators with measuring and monitoring of CAPA program as needed.

 

Job Responsibilities and Essential Duties

 

  • Support CAPA Owners to ensure proper CAPA investigation, action planning, action implementation, and effectiveness check planning and execution. (30%)
  • Support CAPA Owners in ensuring that CAPAs are documented in compliance with applicable standards, regulations, and procedural requirements. (30%)
  • Support CAPA Owners in driving CAPA activities to ensure timely completion throughout all phases of the CAPA process.  (20%)
  • Support CAPA owners with the use of the TrackWise electronic CAPA system to ensure that CAPA records remain in a state of audit readiness.  (10%)
  • Support the CAPA Coordinators with the CAPA Review Board meetings and periodic CAPA trending data.  (10%)

 

Required knowledge, Skills & Abilities

 

  • A Bachelor’s degree in Engineering, Science, or a related field is required.  A Master’s of Science in Engineering, Science, or related field is preferred.
  • Five (5) years hands-on experience with CAPA is required.
  • Must have the ability to autonomously analyze and solve semi-complex problems.
  • Excellent oral and technical writing skills with the ability to interface effectively and professionally across departments and at all reporting levels.
  • Working knowledge of quality systems is required.  Familiarity with analytical software (i.e. Minitab) applications is preferred.
  • Experience with electronic CAPA management programs (i.e. TrackWise) is preferred.
  • Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, or equivalent) is required.

 

 

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The salary range is $95,000 -$115,000 based on experience.

 

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.