Philips Quality Specialist 1 in Nashville, Tennessee
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
The Q&R Specialist is responsible for day to day functions related to quality management system activities and must possess excellent time management skills. The activities within this role require coordination across departments and organizations, and requires the Q&R Specialist to utilize their knowledge of quality methods, processes and applications. This role ensures all departments of APM (Customer Services, Sales, Marketing, Equipment Brokerage, Purchasing, etc.) remain in compliance with all applicable medical device/quality regulations. The Q&R Specialist will work alongside these departments to ensure regulatory alignment within a fast-growing and ever-changing environment.
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
Key areas of responsibilities (KARS) for this role include:
Maintain records and facilitate closure for Quality-related processes such as Customer Feedback/Complaints, Corrective and Preventive Actions, and Risk Management, performing trending and improvement activities as assigned.
Support or Perform Internal Audits for AllParts Medical, generating formal audit reports and submitting those reports to Senior Management.
Perform Document Control activities on AllParts Medical policies, procedures, and forms.
Act as Safety Officer /Environmental Health and Safety designate for AllParts Medical, facilitating site environmental, health & safety compliance through required inspections, document management and communication with site staff. This will include Maintaining OSHA 300 logs, evaluating worksite for EHS hazards and performing accident investigations
Support special projects/work initiatives as assigned.
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces 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 & Audit. As 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.
Philips Healthcare is a highly functional medical device organization where quality management system requirements are highly integrated. At their subsidiary, AllParts Medical (located in North Nashville, TN) the Q&R Specialist will be diligent to ensure the systems within their area of responsibility continue to be supported through information/data/statistical analysis, which includes regular reporting and escalations, as required
We are looking for
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.
Specific skill requirements for this role include:
2 years of experience in a strong Quality System Environment with a minimum of 2 years in a Medical Device company or other highly regulated Industry.
Desired: Academic/ University BS or BA degree; degree in scientific field or business field. (Applicable Work Experience weighs greater than Academic Status)
Experience with Quality methods and tools.
Experience in a FDA regulated environment
Experience with of automated process management tools.
Experience in working within a functional matrix organization desired.
Experience in working with a Training Management System or E-Learning tools preferred.
Proficient use of Microsoft tools for daily work
Familiarity of Medical Device Quality Management System regulations and applicable standards
Must be able to work with numerous cross functional teams and departments
Must possess superior Time Management, Project Management, and Presentation skills
Must be an excellent communicator: The ability to communicate clearly to people across departments and from various functional disciplines is required.
Must be a Team Player, who is both adaptable to change and task driven
When faced with a problem or challenge, the Quality Specialist brings creative solutions to the table within the guidelines of the applicable regulations (an Out-of-the-Box thinker).
Must be a driver for facilitating change in the organization
Familiarity of the following medical device related quality & regulatory standards (not all inclusive): FDA 21 CFR 820 , ISO 13485/ISO 9001, ISO 14971, OSHA
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right 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, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options 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.
Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.
Ready to start improving lives by putting your personal skills & passions to work?
Find out more info about Philips at www.philips.com/na/careers
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.