Quality Engineer PM Consultant

Quality Engineer PM Consultant (Randstad Contingent Worker)

This position will be fully remote and can be home-based anywhere in the US.  

In this role, you will have the opportunity to:

Manage the Quality Management System activities associated with Enterprise Diagnostics Solutions including but not limited to CAPA’s, internal & external audits, document reviews & approvals, record management, training and any additional activities assigned by EDI QMS Manager. 

You will be responsible for:

• Certificate and State licensing management for assigned business category.
• QMS doc review, doc and record Management.
o Maintenance releases
o QMS updates
o Cross functional collaboration to align on shared content
• Post Market Surveillance Update Reports support
• Product Post Market support
• Periodic Document Reviews
• Training Program and KPI management
• Tools validation for NPSS management
• Document control tool workflow management
• QMS implementation, training requests, publishing and repository management (SharePoint).
• Provides QMS and audit guidance to resources
• (prep) invites, SME list, Teams channels, MDSAP gap assessment, agenda review, certs, auditor qual
• (during) SME, back room co-lead, audit request mgmt
• (post) report review, lessons learned
• Audit SME - QMS, Doc Control, Regulatory, QO, PM
• Quality Transition Plan management – audit, OneEDI QMS, PTC Windchill, POPs pilot, Livelink transition, etc.
• Initiative management – Livelink, Windchill, OneEDI QMS, etc.
• FDA Inspection Readiness program.

To succeed in this role, you should have the following skills and experience:

• Bachelor’s, Master's or PhD degree in a scientific or technical field.
• 5+ years of experience in the medical device industry.
• Strong working knowledge of GMP’s and other FDA regulations
• Wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Expert level knowledge of software medical device products and services.
• Regular interactions with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
• Ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
• Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
• Experienced managing a team to deliver business application implementation projects, including experience as an active contributor on projects with scheduled deliverables.
• Experience validating application activities.
• Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.
• Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
• Proven analytical capabilities.
• Excellent communication, organizational, and project management skills.
• Successful experience working with cross-functional teams across multiple work locations.
• Network oriented and able to interact with different business functions and can work within numerous systems.
• Work cooperatively in a team environment.

You will be a part of:

Philips Enterprise Diagnostics Solutions Team

The primary focus of this role is to support the ongoing operations of EDI related to QMS activities while supporting consolidation and standardization efforts.

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.