Engineer I, Quality Complaints - Wayne, NJ

Getinge
Wayne, New Jersey
Report

Job Description

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 Quality Engineer. This position will provide support and assistance in the evaluation of Product Complaints for Medical Device Report and Vigilance reports. Responsible for evaluation of returned samples associated with complaints, risk and label review in accordance with the department procedures and regulatory requirements. This position will interact with the R&D and sustaining engineering and medical professionals to support in the complaint investigations and product quality assessments.


Job Functions:

  • Assist in trending, Product Inquiries, and other activities as required.
  • Identify, initiate, and/or performing product Area activities, as well as other areas within the Quality System including, but not limited to, Internal Audits, Supplier Quality, Nonconforming materials, and HHEs
  • Coordinates procurement/shipment of samples to testing laboratories, evaluation and reporting results.
  • Actively identifies, pursues, and provide recommendations for assuring patient safety and compliance to regulations.
  • Assist the complaint team during regulatory agency, notified body or other 3rd party audits.
  • Engage with different parts of the organization to resolve issues.
  • Assist in writing reports on various complaints metrics.
  • Completing both short and long-term projects/assignments
  • Communicating business related issues or opportunities to next management level.
  • Assist in following up with Sales Representatives.
  • Ensure compliance with all applicable local, state, federal and other applicable regulations.


Required Knowledge, Skills and Abilities:

  • A Bachelor’s degree in Engineering, Science or related field or equivalent experience is required.
  • Zero to two years of experience in complaints quality engineering, or related functions or M.S. and no experience. Experience in a FDA regulated industry or ISO certified organization is preferred.
  • Must have familiarity with laboratory work in the medical devices industry, the ability to analyze and solve problems, and the ability to communicate effectively across departments.
  • Must demonstrate affective time management, project management skills and be able to practice good safety standards and returned products safe handling techniques.
  • Proficiency with Microsoft Office Products such as Word and Excel or equivalent software applications is preferred. Intermediate computer skills are ideal.


Critical thinking - the ability to analyze information objectively and make a reasoned judgment.
Analytical - the ability to carefully examine something, whether it is a problem, a set of data and then understand what it means or what it represents.


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. 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 MedTec company.


Benefits at Getinge:


At Getinge, we offer a comprehensive benefits package, which includes:

  • Health, Dental, and Vision insurance benefits
  • 401k plan with company match
  • Paid Time Off
  • Wellness initiative & Health Assistance Resources
  • Life Insurance
  • Short and Long Term Disability Benefits
  • Health and Dependent Care Flexible Spending Accounts
  • Commuter Benefits
  • Parental and Caregiver Leave
  • Tuition Reimbursement


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.


Getinge
Engineering
Full Time
Onsite
Competitive
See Description for Experience
2 years, 1 month ago