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Engineer II, Quality - Wayne, NJ

Company: Getinge
Location: Wayne
Posted on: September 11, 2022

Job Description:

*Engineer II, Quality **Wayne, NJ**Together we can make a difference!**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 Quality Engineer II in our Compliance team. This position will assist in ensuring compliance to FDA, ISO, and other applicable regulations and standards. It provides technical support for multiple projects primarily within the Cardiac Assist business units, however some cross-over into the Cardiac Surgery/Vascular Intervention business unit may be required as needed. *Job Responsibilities and Essential Duties*
* Manage applicable CAPAs and perform CAPA effectiveness checks as required. (20%)
* Performs external standard assessments to standards, regulations, guidance documents assigned to Quality Compliance. Conducts thorough review of the changes and meets with process owners, as needed, to identify the required actions to be taken to address the changes and potential gaps. (15%)
* Works with Quality Compliance process owners and processes change notices in Windchill. (20%)
* Serves as a front room scribe during third party audits and FDA inspections keeping the back room informed of the topics and points of discussion taking place in the audit room. (5%)
* Supports with regulatory registration application requests. (5%)
* Routing documentation through Adobe e-sign for review/approval. (15%)
* Supports the Internal Audit process by completing internal audit activities as required. (20%)*Required Knowledge, Skills and 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.
* Two (2) years hands-on experience is required, five (5) years hands-on experience is preferred.
* ASQ Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE) or an equivalent is preferred. * 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. *Excellent Opportunity! Excellent Benefits!... Dental, Health, Vision, Life and 401(k) and more!**For immediate consideration, please submit resume.**_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._* We look forward to receiving your application. 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. We hope you will join us on our journey to become the world's most desired medtech company. INDYA Job Type: Full-time Benefits:
* 401(k)
* Dental insurance
* Health insurance
* Life insurance
* Vision insurance
* Monday to Friday Work Location: One location

Keywords: Getinge, Wayne , Engineer II, Quality - Wayne, NJ, Engineering , Wayne, New Jersey

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