Sr. Quality Engineer- QMS/Software
Job TitleSr. Quality Engineer- QMS/Software
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 Sr. Quality Engineer for Software at Philips Wellcentive is accountable for the oversight of quality and risk management throughout the software lifecycle. In addition to product quality related activities the Quality Engineer for Software is responsible for ensuring an effective Quality Management System (QMS) is implemented and maintained throughout the organization.
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:
- Responsible for leading SW quality engineering activities like: Designing SW Quality plans, overseeing the execution of SW Quality Plans, assessing complex software designs and reviewing test and other complex performance data, analyses market feedback, lead complex root cause analysis and complex SW Quality problem solving
- Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle
- Provides effective oversight of: the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle
- Acts as a single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards
- Independently audits the adequacy of design specifications, V&V test plans, and reliability test plans for software validation
- Ensures product related data is collected and analyzed from performance in the field and evaluates it against reliability specifications for software
- Uses post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates and reports field actions when required
- Represents the Supplier Quality function within the Q&R department
- Implements, maintains, and enforces a compliant and effective QMS
- Responsible for ensuring compliance to worldwide QMS/product requirements as required, and ensuring policies/procedures for all products and operations are consistent with those requirements
- Manages (local) Q&R processes and ensures (local) process ownership for all activities in scope
- Actively educates and promotes the QMS to achieve a quality and regulatory compliance culture throughout the organization
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.
Location: Alpharetta, GA
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:
- Bachelor’s engineering degree with > 5 years of related experience, or a Master’s degree with > 3 years of related experience
- Working knowledge of appropriate global medical device or consumer product regulations, requirements, and standards
- 6+ years of related experience in a medical device or regulated industry
- Experience with Agile software development
- ASQ certification as Certified SW Quality Engineer or DfSS Green Belt / Black Belt preferred
- Experience managing a Quality Management System preferred
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.
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.
In case of difficulties with your job application please send an email to [email protected]
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