QMS Engineer

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Job description

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 compliance

• Assuring factory ramp down activities occur without impact to Quality Management Systems and Key Performance Indicators (KPIs)

• 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 as assigned.

• Tracking key quality performance indicators and assisting with metric enhancements.

• Facilitating management review process and coordinating timely implementation of actions.

Responsibilities:

• 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 closure activities.

• 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 responsibility).

• 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 changes.

• 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 process.

• 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 experience:

• BA/BS Degree preferred.

• Experience working in disciplined regulated industry and previous regulatory surveillance experience preferred.

• QMS experience working in medical device or pharmaceutical manufacturer.

• 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 deliverables.

• 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 world.

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 by.

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.