In this role, you have the opportunity to
As Senior Manager of Design Assurance Quality Engineering, the primary responsibility will be to work within the Quality Management System (QMS) to support the design controls process during development of new medical devices. You will apply company policy and procedures to work with supporting team members to analyze situations or data and draw conclusions. Assignments will include creating, reviewing and updating documents, review of product requirements, development of risk management files, auditing Design History Files and actively participating as a core team lead of new product development teams as well as supporting teammates who act as core team leads on new product development projects. The Senior Manager of Design Assurance will also update existing QMS procedures and create new QMS procedures.
You are responsible for
Drive engagement within and develop Design Assurance team members
Ensure that NPI projects are adequately staffed and supported
Understand and implement processes and intent of all aspects of the QMS related to Design Controls
Using engineering principles, analyze situations or data to identify gaps between project work and QMS
Work with teams and other Design Assurance team members to ensure compliance to the QMS
Develop mastery of our products and analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles
Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects
Strong understanding of shelf life and biocompatibility testing
Create and facilitate updates to product risk analyses and risk management files
Develop and implement new and improved quality/compliant pre-market engineering methods, techniques and processes.
Build stable relationships internally
Manage department to budget
You are a part of
As a result of Philips renewed dedication to Quality, it has recently restructured its organization to ensure you and your department have clear collaboration 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.
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.
BS in Engineering, Sciences, or a related field. MS preferred.
8+ years’ experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a highly regulated industry. 5+ years’ experience with a MS or higher.
New product development experience preferred
5+ years’ experience leading and managing people.
Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR
Strong understanding of design quality tools, methods and activities
Strong statistical background preferred in reliability / verification, hypothesis testing, sampling, multi-factor analyses
Demonstrated expertise in managing complex projects and implementing cultural change.
Excellent customer service and interpersonal communication skills, including regularly leading presentations in front of peers and leadership.
Excellent teamwork skills including influencing and building rapport with internal customers and stakeholders
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.
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 regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
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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