Job Description

Engineer II, Quality Compliance - Wayne, NJ Together we can make a difference! 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 \xe2\x80\x93 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\xc2\xb0C 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 individual 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. Responsibilities Include:

• Support the initiation and assignment of CAPAs as required.
• Support CAPA Owners to ensure proper CAPA investigation, action planning, action implementation, and effectiveness check planning and execution.
• Support CAPA Owners in ensuring that CAPAs are documented in compliance with applicable standards, regulations, and procedural requirements.
• Support CAPA Owners in driving CAPA activities to ensure timely completion throughout all phases of the CAPA process.
• Support CAPA Owners with the use of the TrackWise electronic CAPA system to ensure that CAPA records remain in a state of audit readiness.
• Support measuring and monitoring of the CAPA program.
• Lead periodic CAPA Review Board meetings.

The ideal candidate must possess:

• A Bachelor\xe2\x80\x99s degree in Engineering, Science, or a related field is required. A Master\xe2\x80\x99s of Science in Engineering, Science, or related field is preferred.
• Two years hands-on experience with CAPA is required.
• 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.

Getinge is on an exciting\xe2\x80\xaftransformation journey constantly looking for new ways to innovate together with our customers\xe2\x80\xafto meet the healthcare challenges of the future. Our passionate\xe2\x80\xafpeople hold our brand promise \xe2\x80\x98Passion for Life\xe2\x80\x99 close to heart. If\xe2\x80\xafyou\xe2\x80\xafshare\xe2\x80\xafour\xe2\x80\xafpassion\xe2\x80\xafand\xe2\x80\xafbelieve\xe2\x80\xafthat\xe2\x80\xafsaving\xe2\x80\xaflives\xe2\x80\xafis\xe2\x80\xafthe\xe2\x80\xafgreatest\xe2\x80\xafjob\xe2\x80\xafin\xe2\x80\xafthe world, then\xe2\x80\xafwe\xe2\x80\xaflook forward\xe2\x80\xafto\xe2\x80\xafreceiving\xe2\x80\xafyour\xe2\x80\xafapplication and resume. We hope you will join us on our journey to become the world\xe2\x80\x99s most respected and trusted MedTec company. Position Eligible for Remote Work: 1-2 days Salary Range: $90K-$100K / year 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

Excellent Opportunity to join an industry leader! Interested candidates please send your 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\xe2\x80\x99s most desired medtech company. INDNM Job Type: Full-time Pay: $90,000.00 - $100,000.00 per year Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Tuition reimbursement
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Work setting:

• In-person

Work Location: One location

• Health insurance