QMS Quality Engineer
Posted on: November 22, 2021
QMS Quality Engineer (Randstad Contingent Worker)
In this role, you will have the opportunity to:
The challenge for the QMS Engineer is ensuring the local QMS and
its key processes meets Philips and Global standards. This is a key
role in our business- working with the Director, Q&R team,
leadership team and key process owners to achieve zero defects and
full compliance. This role reports to the Director Q&R.
You will be responsible for:
Key Elements of the Role:
--- Daily, on-site support of Gainesville Florida site for
coordinating factory 5S activities to achieve continuous cGMP
--- Assuring factory ramp down activities occur without impact to
Quality Management Systems and Key Performance Indicators
--- Assuring compliance with external standards as well as
corporate policies and procedures for continuous improvement.
--- Facilitating the CAPA process and ensuring appropriate
documentation. Internal Auditing (process and compliance) and
assisting with process improvements.
--- Assisting with Complaint Handling and owning individual events
--- Tracking key quality performance indicators and assisting with
--- Facilitating management review process and coordinating timely
implementation of actions.
--- Maintains and enforces a compliant and effective QMS for the
activities in scope, as well as for effective and lean QMS
structures and documents for Q&R processes.
--- Performs regulatory surveillance (FDA, EU, UL, IEC, etc---) gap
--- Internal and external audit support as well as support of key
QA processes (CAPA, complaints, auditing, QMS reviews, management
review, metrics gathering and operation's projects).
--- Facilitates the transition/ deployment of the PQMS, and
coordinate its deployment.
--- Assists with oversight of QMS- assure policies, procedures and
instructions in place to support ISO-9001, ISO-14001, PED/ASME and
Corporate Requirements, (ie: ISO-13485) working with local document
control team and functional Leaders (who share QMS ownership
--- Maintains close integration with site leaders and facility
partners to drive continuous improvement activities.
--- Participates in procedure updates, assuring new items and
updates are incorporated in the local QMS in a timely manner and
assisting with the formal assessment of changes for local QMS
--- Assists with external audits (PH, ISO, EHS), audit responses
and timely resolution.
--- Supports Business Partners with problem solving tools & data to
drive continuous improvement,
--- Identifies areas of risk to compliance via proactive
monitoring, developing and driving corrective and preventive action
plans and assists with the execution of Philips Excellence quality
--- Engage with global partners to share best practices,
development, and monitoring and driving improvement of key metrics,
participation in the budgeting and planning processes.
--- Assist with other activities as assigned.
To succeed in this role, you should have the following skills and
--- BA/BS Degree preferred.
--- Experience working in disciplined regulated industry and
previous regulatory surveillance experience preferred.
--- QMS experience working in medical device or pharmaceutical
--- Experience with implementing a quality system that is ISO 9001
/ ISO 13485 or FDA CFR 820 compliant.
--- Demonstrated ability to understand and develop processes.
--- Experience with business application implementation projects,
including being an active contributor on projects with scheduled
--- Demonstrated ability to interact and communicate in English,
including demonstrable writing, speaking, and comprehension skills;
ability to communicate across levels of the organization.
--- Experience working in a Lean environment.
--- Computer / software proficiency (Excel, MS Word, Visio)
You will be a part of:
You are empowered to use your voice and expertise to have a
positive impact on your team, the business, and health technologies
that will improve the health, well-being and care for people around
In return, we offer you:
Philips welcomes you to a challenging, innovative environment with
great opportunities for you to explore and grow.
Quality is on the top of Philips leadership agenda and that means
you have the unique opportunity to come in and have a recognized
voice to drive and witness exciting, transformational changes. You
will be empowered to drive high quality, groundbreaking innovations
with a globally recognized, premium brand behind you. And when you
are successful in this role you will have an array of diverse
career opportunities open to you - across different functional
areas, product lines, business groups and/or geographies. That is a
commitment Philips Quality Leadership team has made and stands
Why work on a project at Philips?
If you're looking for meaningful work and a chance to tackle
complex challenges, broaden your skills and expertise and become an
even more sought after professional, you'll find all that and more
with project work at Philips.
The Randstad companies are responsible for finding talent to
provide services at Philips. If you are selected to provide
services for Philips, you will be employed by Randstad and will not
be an employee of Philips.
Keywords: philips, Gainesville , QMS Quality Engineer, Other , Hawthorne, Florida
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