In this role, you have the opportunity to
Join the Quality & Regulatory team and working on projects with focus on improvement and implementation of New Product Design and Development processes, Design Controls, Risk Management and initiatives for meeting regulation requirements and improving compliance. The Senior Manager, Design Quality Assurance Engineering is accountable for oversight of system and devices quality and risk management throughout the product life cycle. The Senior Manager, Design Quality Assurance Engineering provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The Senior Manager, Design Quality Assurance also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes.
You are responsible for
Responsible for leading quality assurance teams for activities like: Designing quality plans, overseeing the execution of quality plans, assessing complex product design, reviewing test and other complex performance data, analyses market feedback, lead complex root cause analysis and complex quality problem solving.
Support all quality assurance activities which will includes but not limited to: Design compliance to internal procedures and regulatory requirements, Risk management (FMEAs, hazard analysis, fault tree analysis)
Serve as subject matter expert for the application of design controls per regulatory expectations
Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
Establishes and assures adherence to budgets, schedules, work plans, and performance requirements
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 responsible to ensure that device design meets quality and compliance standards for every landmark
Responsible for building and leading a Quality Assurance competence: organizing, leading Quality Assurance activities on organization unit level.
Provides multi-functional leadership for the Product Quality function in all aspects of the Business Unit or Market initiatives
Frequently interacts with engineers, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company. Often must lead a cooperative effort among members of a project team
Ensures compliance activities (such as CAPAs) are appropriately resourced and managed
To succeed in this role, you should have the following skills and experience
A Masters or Bachelor Degree in Engineering, Quality or Business Management
Minimum 8 years’ experience in Quality and Regulatory with medical devices
Strong knowledge of Design controls, Risk Management, Design for Six Sigma tools and its application
An expert understanding of medical device industry regulatory requirements including but not limited to MDSAP participating countries, ISO Standards (ISO 13485 and ISO 14971), EUMDR, IEC 62304, IEC 60601, IEC 62366.
Electrical and software development experience is preferred
Leadership experience and good change management and influencing skills required
Experience in a larger multinational company is required
Ability to train, coach and motivate people.
Enthusiastic and able to act on own initiative
Excellent organizational skills to lead and track deliverables
Strong influencing skills; power of persuasion, perseverance, getting things done mentality.
Experience/certified in project & change management preferred
Strong Analytical and Statistical skills
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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