Quality Engineer 2

Purpose: Company: Siemens Medical Solutions USA, Inc.

Division: SMS - Angiography Division

Req ID: 43559

Position Title: Quality Engineer 2

Company Description:
We are one of the largest global suppliers of healthcare equipment, renowned for innovative products, services and solutions including diagnostic imaging systems, therapy equipment for treatment and electromedicine and IT solutions to optimize workflow and increase efficiency in the healthcare industry.

Siemens is an Equal Opportunity Employer encouraging diversity in the workplace.

Job Description:


Do you have what it takes to work for a global Fortune 50 company? Are you
looking for an opportunity to push your skills to the next level? If you are
driven to create innovative solutions that take healthcare to the next level-
you may be just the person we’re looking for.


Siemens Medical Solutions designs equipment and software for the
healthcare industry. We improve the way healthcare is delivered each and every
day. We are looking for determined, focused and passionate individuals who care
as much about changing healthcare as we do. This could be your opportunity to
work for an industry leader- are you ready for the challenge? If so, it will
open a world of opportunities to you.


Siemens Medical Solutions, Inc. has an opening for a Quality Engineer in our Cardiology Solutions department developing
Cardiac Cath Lab products. The position is located at our office in Hoffman Estates, IL.


Position Description: The Quality Engineer in our organization is responsible for:


Verifying the correctness of quality system related work products and
development results

Compliance of work product with the Quality Management Plan and authorization
of their release

Review and approve product risk management documentation

Participation and guidance of Change Control Board meetings

Participation in internal and external audits

Participating in reviews according to Product Lifecycle Management (PLM)
process requirements

Verification
and assessment of the completeness of Design History Files (DHF) and Device Master Records
(DMR)

Requesting process changes in case of deviations



The following are specific responsibilities of the Quality Engineer:


Contact person for questions about compliance and regulatory requirements
to follow due PLM processes

Assist project management with the Quality Management Plan

Support project management with the assessment of process and project conformity
during main reviews



Experience and Competencies: 3+ years of quality engineering experience preferably in a medical device or other regulated product development organization. Good understanding of
FDA Quality System Regulations (QSR) and Good Manufacturing Practice (GMP) as
well as Medical Device Directive (MDD). CQE certification a plus.


Excellent knowledge about PLM and PLM related processes in the medical
device industry

Knowledge of quality, regulative, normative, and legal requirements in
the medical device industry

Good understanding of Software Quality Assurance (SQA)

Excellent interpersonal, written and verbal communication skills to communicate information effectively to
project management, managers, and technical staff.

Ability to work in a fast-paced, deadline oriented environment as part of a team.

Produce excellent results with minimal supervision.

Strong analytic and decision-making skills.

Strong quality orientation and customer focus.

Interaction and collaboration with several departments and locations
around the world.

Occasional domestic and international travel required.



Education/Equivalent Training Required: BS in Engineering, training in
FDA QSR, cGMP, MDD

Compensation:
There is assistance available for relocation.
Job Requirements:
Travel Percentage: 10%


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