You are responsible for
Key member of product design and development project teams, including HW and SW development
Independently audits the adequacy of design specifications, V&V test plans and reliability test plans for software validation
Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design.
Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle
Performs independent technical assessment on product quality performance and post-market product quality analysis
Can Lead quality related problem solving and root cause analysis during design and manufacturing
Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
Act as a single point of contact (person assigned to project team) responsible to ensure that product design meets quality and compliance standards for every milestone
Independently produces and completes Quality Engineering Documents.
Responsible for performing timely, quality engineering tasks like: Assessing quality plans, assessing product designs and reviewing test and other performance data, analyses market feedback, lead root cause analysis and quality problem solving.
May also provide other quality engineering support, including assisting organizational units in leading quality engineering improvement efforts
Ensure the maintenance of the original configuration of requirements documentation, design documentation, software and related documentation in accordance to IEC62304 and QMS processes
Sign-off on and ensure completion, compliance, and auditability of all QMS-relevant requirements (incl. review and verification of documentation and metrics) at Product Realization Process milestones
Develop / update process and identify tools required to ensure completeness and auditability of all QMS compliance criteria at PRP milestones
Actively educates and promotes the QMS to achieve a quality and regulatory compliance culture throughout the organization
Advise 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.
Oversee quality and risk management throughout the software lifecycle
Support maintenance and updates as necessary of the Quality Management System (QMS) procedures
Assist in managing Philips relationships with notified bodies and approval agencies such as the US Federal Drug Administration (FDA).
You are a part of
The successful candidate will be a highly valued member of the Aging and Caregiving business within Philips HealthTech organization located in Framingham, MA and also supporting design team in Vancouver, Canada.
To succeed in this role, you should have the following skills and experience
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Minimum 3 to 5 years work experience in regulated Medical Device Quality Assurance environment
Experience working with a software development teams using SAFe/Agile methodology
Skilled in the preparation of Regulatory Assessments and Regulatory Plans
Development and maintenance of product risk management files
Experience with international product compliance testing requirements
Understanding of and experience with the regulations and standards:
FDA Quality Systems Regulations
IEC 60601 (including collateral standards for EMC and medical devices intended for home use)
Telecommunications regulations for operator safety (FCC and cellular provider Certifications)
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 . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
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 blog . Once 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 to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.