Engineer II, Quality - Wayne, NJ

Full Time
Wayne, NJ 07470
Posted
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 II. This position will support the Cardiac Assist (CA) and Cardiac Surgery (CS) business areas. It will be responsible for providing 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 with teams.


Job Responsibilities and Essential Duties

  • 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.


Required Knowledge, Skills and Abilities


  • 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.
  • 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. 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.

smogtown13.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, smogtown13.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, smogtown13.com is the ideal place to find your next job.

Intrested in this job?

Related Jobs

All Related Listed jobs