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Head of Design Quality Assurance, Compliance and Safety

Company: Philips Electronics North America Corporation
Location: Pittsburgh
Posted on: October 15, 2021

Job Description:

Job Title

Head of Design Quality Assurance, Compliance and Safety

Job Description

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.

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 Head of Design Quality Assurance, Compliance & Safety is accountable for oversight of system and devices quality and risk management throughout the product life cycle. The Head of Design Quality Assurance, Compliance & Safety 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 Head of Design Quality Assurance, Compliance & Safety 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
  • Manage planning, staffing, budgeting, & expense priorities for a key department within the SRC organization including managing Standards Compliance Lab and Cleaning and Disinfection Labs
  • Conduct annual performance reviews, manage talent development, and succession planning to ensure we have the best talent within the organization.
  • Interactions frequently involve negotiating with customers, management, and interfacing with senior/executive level leaders regarding matters of significance to the organization for a business > $2 Billion.

You are a part of

This position resides in the Sleep & Respiratory Care Business Group, a business group of Philips HealthTech. We are highly dynamic, ambitious, and agile within a fast-changing industry. Our vision is to work together with our clinical and consumer customers to transform the personalized healthcare market to meet the significant demands caused by the increase of chronic conditions and an aging society. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions.

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.
  • B.S. in a technical field, Electrical, Mechanical, Software Engineering etc. Masters degree preferred.
  • 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
  • Expertise with Design Quality, Reliability and Safety/Compliance is a must.
  • ASQ certifications (CQE, CRE, CMQ/OE etc) Preferred.
  • 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.
  • Excellent organizational skills to lead and track deliverables
  • 8+ years of experience leading a team
  • Ability to clearly connect with your team to set direction and to communicate concisely with senior management to provide periodic updates
  • Effective team leader. Able to mentor and empower a team, set strategy and evaluate proficiencies present and needed for department growth.

In return, we offer you

A path towards your most exciting career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a sophisticated 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. 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 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.

Equal Employment and Opportunity Employer/Disabled/Veteran



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Keywords: Philips Electronics North America Corporation, Pittsburgh , Head of Design Quality Assurance, Compliance and Safety, Other , Pittsburgh, Pennsylvania

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