Head of Design Quality Assurance, Compliance and Safety
Company: Philips Electronics North America Corporation
Posted on: October 15, 2021
Head of Design Quality Assurance, Compliance and Safety
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
- 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
- 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
- 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
- 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
- US work authorization is a precondition of employment. The
company will not consider candidates who require sponsorship for a
- B.S. in a technical field, Electrical, Mechanical, Software
Engineering etc. Masters degree preferred.
- Electrical and software development experience is
- 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
- 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
- Effective team leader. Able to mentor and empower a team, set
strategy and evaluate proficiencies present and needed for
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
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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