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
Assure international regulatory and legal compliance of the philips quality system(s) and company-wide compliance with philips quality policies, quality objectives, and quality standardsResponsible to perform timely, detailed, and independent internal quality management system (qms), product-focused, and/or clinical audits to assess regulatory compliance to applicable local and international regulations/standards and philips requirements.
You are responsible for
Plan, coordinate, and execute internal qms and/or product-focused audits to assess the compliance and effectiveness of the overall qms of the organizational unit(s) under audit.
Review responses to audit findings for completeness and effectiveness.
Perform timely, detailed, and independent internal quality management system (qms), process audits, or product-focused audits.
Participates in quality & regulatory initiatives as a cross functional contributor
Maintains and administers audit management tool content and associated records
Onsite audit execution where local restrictions allow
You are a part of
As a result of philips renewed dedication to quality, it has recently restructured its organization to ensure you and your department have clear collaboration with philips business group and market leadership, and can harness the expertise of five centers of excellence (coes)These 5 coes specialize in the following capabilities: regulatory & clinical affairs, supplier quality, quality management system, quality assurance & engineering, and compliance & auditAs part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you should have the following skills and experience
Bachelor’s degree, or equivalent
Qualified lead auditor according to philips q&r internal audit process requirements.
Current certification with a recognized accreditation body (i.eExemplar global/irca) or successful completion of asq certification as a certified quality auditor (cqa) and/or certified biomedical auditor (cba) or successful completion of a suitably equivalent lead auditor course.
Current audit training/experience
Working knowledge of global governing regulations, requirements, and standards such as 21cfr parts 803, 806, 820, 11; iso 13485, iso 9001, iso 14971, european medical devices directive (93/42/eec), eurpoean medical device regulation, (2017/745), canadian medical devices regulation (sor/98-282), and japanese mhlw ordinance 169.
Strong capa knowledge and experience.
Participation in at least 2 philips q&r internal audit within the last 12 months (preferred)
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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