Manager, Quality Operations

 

 

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 Manager, Quality Operations, CA. This position is responsible for ensuring there are compliant manufacturing processes and has oversight for the Quality Control activities, for Cardiac Assist Hardware & Disposables, related to Production and Process Controls, incoming, in-process and Finished device acceptance testing and release. This role will lead and manage the Quality Operations teams to ensure the highest standards of product quality and regulatory compliance in the manufacturing, and distribution of medical devices. This role is crucial in overseeing the implementation of quality systems, driving continuous improvement initiatives, and ensuring compliance with all relevant regulatory standards. This role will be responsible to ensure new product design transfer and design change activities are executed to the plan and compliant. Oversees sites Master Validation plan for equipment and processes.

 

Job Responsibilities

• Manages the following:

• Quality Control activities related to In-process and finished device acceptance testing and release,
• Supports and Partners with Incoming Quality Control. Ensure compliance standards and applicable government regulations,
• Supports the Calibration department ensuring compliance standards and practices are maintained.
• Provide mentorship, training, and performance management for the quality team members.

• Leads the following:

• Production and Process Controls monitoring and improvements,
• KPI reporting,
• Investigations of process and product non conformances including NCMR’s (Nonconforming Material Reports) and CAPA’s,
• Kaizen and GEMBA walks,

• Communication and coordination activities related to the release of final product, including ship holds and field actions,
• Quality Manageme