Philips Quality & Regulatory Systems Specialist in Andover, Massachusetts

Your Responsibilities:

  • Author and/or review application validation documents which are compliant with NPSS procedures and associated documents. Monitor documents and update as needed. Execute validation activities, per assigned role, which results in our customers’ acceptance of the application.

  • Review and provide input on technical specification validation documents to ensure the system design will meet our customer’s requirements and objectives.

  • Review and provide input on software validation processes to ensure compliance with NPSS procedures and regulatory requirements.

  • Coordinate and support the deployment of new functionality to current users.

  • Draft, submit for approval and monitor change requests needed to support compliance to regulatory standards and to improve business processing.

  • Develop, maintain and deliver software application training content which is instructive, easy to follow and value-added for our customers.

  • Provide efficient and effective email and website communication to our customers concerning topics such as application status, changes and training.

  • Identify, develop and implement queries and reports which require administrative permissions or a high degree of system knowledge which cannot be transferred easily to our customer.

  • Lead standard tool deployments (roll outs which do not require configuration changes to workflows or functionality) across Philips as needed.

Your Profile:

  • 5+ years of experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, GAMP 5

  • Strong knowledge of software validation

  • Experience in executing validations of application systems

  • Experience with business application implementation projects including being an active contributor on projects with deliverables per a project timeline

  • Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues

  • Demonstrated ability to understand and develop processes

  • Results oriented and resourceful individual with solid leadership and interpersonal skills

  • Demonstrated ability to interact and communicate (both oral and written) in Standard English, including demonstrable writing skills, speaking, and comprehension; ability to communicate across levels of the organization

  • Strong Business Partnering skills

  • Strong PC skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications

  • Ability to create ad hoc reports as needed per requestor specifications and agreed upon dates

  • BA/BS degree required

In this role, you have the opportunity to

Review and provide input on technical specification validation documents to ensure the system design will meet our customer’s requirements and objectives.

Your Responsibilities:

  • Author and/or review application validation documents which are compliant with NPSS procedures and associated documents. Monitor documents and update as needed. Execute validation activities, per assigned role, which results in our customers’ acceptance of the application.

  • Review and provide input on software validation processes to ensure compliance with NPSS procedures and regulatory requirements.

  • Coordinate and support the deployment of new functionality to current users.

  • Draft, submit for approval and monitor change requests needed to support compliance to regulatory standards and to improve business processing.

  • Develop, maintain and deliver software application training content which is instructive, easy to follow and value-added for our customers.

  • Provide efficient and effective email and website communication to our customers concerning topics such as application status, changes and training.

  • Identify, develop and implement queries and reports which require administrative permissions or a high degree of system knowledge which cannot be transferred easily to our customer.

  • Lead standard tool deployments (roll outs which do not require configuration changes to workflows or functionality) across Philips as needed.

You are Part of

The Quality System Subject Matter Expert for ValGenesis is a vital organizational role in support of the ValGenesis application and Non Product System Software (NPSS).

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

  • 5+ years of experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, GAMP 5

  • Strong knowledge of software validation

  • Experience in executing validations of application systems

  • Experience with business application implementation projects including being an active contributor on projects with deliverables per a project timeline

  • Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues

  • Demonstrated ability to understand and develop processes

  • Results oriented and resourceful individual with solid leadership and interpersonal skills

  • Demonstrated ability to interact and communicate (both oral and written) in Standard English, including demonstrable writing skills, speaking, and comprehension; ability to communicate across levels of the organization

  • Strong Business Partnering skills

  • Strong PC skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications

  • Ability to create ad hoc reports as needed per requestor specifications and agreed upon dates

  • BA/BS degree required

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.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

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.

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