Philips Labeling Systems Quality Engineer – Medical Device Springs CO 

United States, Colorado, Colorado Springs 

576589981

You will sustain and maintain labeling system software, hardware and processes in a medical device manufacturing environment.

Your role:

• Develop and maintain a complete labeling system (software, processes and equipment) for complex medical devices.

• You are responsible for: the development sustaining of a complete labeling system solution software; the quality and compliance of medical device labeling; internal and external database management; validation activities (software and hardware); and departmental work instructions/processes.

• Deployment and administration of a complete labeling system, including documented Work Instructions (WIs) and departmental Standard Operating Procedures (SOPs).

• Ensuring timely change management of labeling and Instructions For Use (IFUs), working with labeling technicians/label coordinators, and performing labeling changes.

• Quality management and all life-cycle phases of product labeling and IFUs. Leadership, both direct and indirect, will be an expectation of this role as a growth path.

You're the right fit if:

• You’ve acquired 1+ year of engineering experience in medical device or other highly regulated industry.
  Your skills include supporting quality related investigations and changes involving labeling materials and/or labeling processes, such as NCRs, CAPA, SICRs, IIAs, Audit Support questions, Equipment Events, Regulatory Gap Assessments, etc.

• You have a B.S. in Engineering.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

• You’re an excellent communicator that is detail oriented and well organized.

How we work together:

This is an office-based role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about .

• Discover

• Learn more about

• Learn more about

The pay range for this position in CO is $71,250 to $114,000

Additional Information:

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Plymouth, MN .