In this role, you will have the ability to manage the quality management system in accordance with company and medical device regulatory requirements for the Columbus, Ohio location of the Cleveland Parts Organization (CPO). Additional responsibilities include certifications and approvals.
You are responsible for
Transition existing QMS from ISO 13485:2003 to ISO 13485:2016.
Work with appropriate certifying bodies to obtain ISO13458:2016 certification.
Ensuring the quality system meets 21CFR820 requirements.
Directly responsible for implementation, governance and maintenance of the department quality system, reporting on the performance of the quality system for review and as a basis for improvement of the quality system.
Execute a risk-based approach to the implementation and improvement of the quality system.
Ensure employees are aware of and comply with all regulatory, customer requirements and regulations.
Responsibility to act as the liaison with external parties on matters relating to the quality system that include regulatory, customer and third party audits. Act as Department Management Representative and coordinate all audits, inclusive of schedules, communication, reports and tracking follow-up actions.
Responsible for promotion of the quality and regulatory requirements through internal staff trainings.
Interface with Business Unit functions as needed to resolve regulatory concerns for assigned products and services.
Analyze and recommend appropriate changes of the procedures/processes as they relate to regulation changes.
Develop and maintain the internal audit function and identify improvement opportunities.
Remain current in all aspects of regulatory and quality system requirements.
Develop and maintain corrective/preventative action program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion and periodic reports.
Lead FDA registration process as required.
To succeed in this role, you should have the following skills and experience
BS or BS from an accredited college or university in a related field, or equivalent work experience.
5+ years in a quality management role
ISO 9001 required, ISO 13485 knowledge a plus
Demonstrate competency in decision-making, flexibility, planning and organizing, self-initiative and interpersonal skills.
Excellent organizational, writing and communication skills.
Strong analytical skills.
Ability to multi-task, prioritize tasks and quickly adjust in a rapidly changing environment.
Experience with the development and certification of a site QMS to ISO standards.
Experience with control processes, quality systems and regulatory practices.
Demonstrated understanding of computer-related equipment, including but not limited to desktop computers, laptops, printers, servers, network systems, software, and electronic databases.
Proficient in MS Office
Risk Management training as it relates to the business requirements.
MDSAP knowledge and experience a plus.
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
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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.