Compliance Specialist / Document Control
This role can be fully remote and can work from anywhere in the US.
In this role, you will have the opportunity to:
Be a key contributor to organizational quality initiatives through your support of document control activities and processing Engineering Change Orders.
You will be responsible for:
• Responsible for creating, reviewing and processing Engineering Change Orders for accuracy
• Create Part number & document numbers
• Familiar with Device Master Record (DMR) and Design History File (DHF)
• Responsible for logging and maintenance of the CO Tracking database, tracking it from inception through release.
• Performing and completing various miscellaneous Document Control tasks when assigned.
• Support Change Control Board (CCB)
• Collect and maintain documents & records of the latest revision level.
• maintain the document management system and ensure fast retrieval of documents and records
• Understanding of the engineering change order (ECO) process.
• Perform the ECO process: collaborate with all affected associates and ensure that ECOs meet QMS requirements.
• Execute engineering change orders in a document management system.
To succeed in this role, you should have the following skills and experience:
• Knowledge of SAP is a plus
• 3-5 years related experience in change control and / or document control field in medical device industry
• Familiarity with Document Management System tools.
• Knowledge of ISO 13485:2016, 21 CFR FDA regulation
• Ability to operate efficiently and effectively in a fast-paced environment.
• Excellent communication, organizational skills.
You will be a part of:
You will be part of the Hospital Respiratory Care PQMS team.
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.