Sr. Quality Engineer - CAPA Compliance

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

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 affect the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.

 

We focus 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 to join our team.

 

We currently have an open position for a Sr. Quality Engineer.  This position will work across the Cardiac Assist (CA) business areas of the New Jersey sites. This role leads and/or provides support for activities to ensure QMS Compliance, with an emphasis on the Corrective and Preventive Action (CAPA) process.  The ideal candidate will effectively:

• Dive cross-functional problem-solving teams to maintain timeliness of CAPA activities and associated documentation.
• Provide guidance to ensure though Investigation to support Root Cause and Action plans to improve product/process.
• Support measuring and monitoring of CAPA program as needed.
• Support oversight of QMS processes, specifically Management Controls.

 

Job Responsibilities

CAPA Management:

• Support the initiation and assignment of CAPAs as required.
• Support/ guide CAPA Owners to ensure proper CAPA investigation, action planning, action implementation, and effectiveness check planning and execution. Ensure the Effectiveness Check addresses the problem statement.
• Support CAPA Owners in driving CAPA activities to ensure timely completion throughout all phases of the CAPA process.
• As CAPA Coordinator, support CAPA Owner/ team on navigating the CAPA process. Assisting them to highlight any perceived RISK that could lead to undue delays.
• Support CAPA Owners in ensuring that CAPAs are documented in compliance with applicable standards, regulations, and procedural requirements.
• 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.
• Be the CAPA Process SME at audits and