Job details
Job type full-time
Full job description
Job description
If you are a colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon requestYou may c ontact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to:
Support & transform philips isc (integrated supply chain) qms with the design and implementation of processes for publication in the global management system and ensure proper linkage with change processes and solution change processesAct as subject matter expert in support of document control processesand it toolsHelp set-up, manage and coordinate isc change control boardYou will gain exposure to cross-functional teams including it, quality & regulatory, and the many manufacturing organizations across philips.
You are responsible for:
Establishes and manages proper document review processes.
Workflow management (load, initiate workflow, review and approve documented information).
Ensure efficient and effective execution of isc qms change control operations (drive acceptability of change packages throughout the change process, ensure change packages meet minimum level of completion before allowing next step in change process, ensure appropriate roles assigned to approve each change, ensure consistency across all controlled items).
Establishes document & record support to authors and (local) process owners in defining and producing lean quality system documents and records; ensure proper quality of the content of documentation and records
Ensure adequate support for change control stakeholders, processing changes in isc qms.
Leads and supports (global) authors of controlled documents to be lean, well accessible, easy to maintain and according to the agreed look and feel.
Provide input to metrics on change control processes performance for isc qms content.
Ensure the structure of database object and models are configured correct in isc qms
Ensures proper documented information metadata management (classification, sorting, filing and proper archiving).
Execution of documented information review processes.
Effective business process ownership/ expert role for document control processes and tools in scope.
Leads and supports lower level document control specialists.
You are a part of:
The isc pqms team within global quality operationsThe document control specialist will be the subject matter expert for isc qms application.
To succeed in this role, you should have the following skills and experience:
Bachelor’s degree in business, sciences, quality management or related field, or equivalent professional experience
3-5 years of experience in the medical device industry
Familiarity with global medical device regulations, requirements, and standards to support process planning and resource designation a distinct advantage
Preferable level working knowledge of agile plm system, opentext, aris, windchill
Ability to operate efficiently and effectively in a fast-paced environment
Fluent in both written and verbal english
Proven experience with change control and document control processes is required
Understanding and working knowledge of appropriate global regulations, requirements, and standards such as 21 cfr part 820, iso 13485, iso 9001Mdsap experience a plus.
Understanding of workflow management in it solutions
Fluent in both written and verbal english
In return, we offer you
A path towards your most rewarding careerPhilips is growing its marketing capability enterprise wideSucceeding in this global role in a complex environment will open many doors for your long term career, in other areas in philips or otherwiseWe also believe that we are at our best as a company when you are at yours as a personThus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activitiesFurthermore, philips university is available to all employees for learning and development opportunities.
Why should you join philips?
Working at philips is more than a jobIt’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 continuumOur people experience a variety of unexpected moments when their lives and careers come together in meaningful waysLearn more by watching this video.
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 blogOnce 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 race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, philips is committed to a diverse workforceIn 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.
Equal employment and opportunity employer/disabled/veteran
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