Document Control Specialist

Philips Carlsbad , CA 92008

Posted 2 weeks ago

Job Title

Document Control Specialist

Job Description

In this role, you have the opportunity to

Oversee and perform all DRC activities to ensure documentation and records are properly controlled, maintained and preserved in accordance to applicable regulations, quality standards and Philips Policies.

You are responsible for

  • Creating, reviewing and processing Engineering Change Orders for accuracy

  • Creating Part number & document numbers

  • Supporting new product introductions and sustaining products with respect to change control

  • Collecting and maintaining documents & records of the latest revision level.

  • Maintaining the doc

Ument management system and ensure fast retrieval of documents and records

  • Receiving initial requests for new/revised controlled documents.

  • Researching and reviewing each request for accuracy. If a problem has been noted, request additional information from the originator and/or schedule a meeting to review submitted documentation.

  • Logging and maintenance of the CO Tracking database, tracking it from inception through release.

  • Performing and completing various miscellaneous tasks when assigned.

  • Supporting Change Control Board (CCB)

  • Notifying Users of ECO Release

You are a part of

An organization that believes-what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It is our mission to improve people's lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.

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

  • Bachelor's degree and a minimum of 3 years of related experience in the medical device or other FDA/ISO regulated industry

  • Understanding of appropriate global medical device regulations, requirements and standards, including of the following is a plus: FDA's 21 CFR Parts 50, 54, 56, 803, 806, and 812, 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, ISO 14155, and ICH E6.

  • Government/regulatory-body Quality System auditing/inspection experience (i.e., former FDA preferred)

  • Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating exibility in prioritizing and completing tasks and communicating potential conicts to a supervisor

  • Attention to detail, organized and self-driven

  • Solid interpersonal and communication skills

  • Ability to communicate effectively both orally and in writing; smart technical writing skills a must

  • Effective time management; able to balance multiple projects simultaneously

  • Open to other's ideas and working collaboratively across functions and/or businesses throughout all levels of the organization

  • Strong computer and technical writing skills a must.

In return, we offer you

The opportunity to work in the medical industry, which brings much fulfillment, as well as unique opportunities to grow. By taking pride in all you do and inspiring others around you to prioritize quality above all else, you'll be contributing to a higher Quality of life for billions and helping Philips deliver innovation that matters.

Why should you join Philips?

Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.



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Document Control Specialist