Senior Manager, Design Quality Assurance Engineering (Software & Systems)
Company: Philips
Location: San Diego
Posted on: January 15, 2021
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Job Description:
Job TitleSenior Manager, Design Quality Assurance Engineering
(Software & Systems)Job DescriptionIn this role, you have the
opportunity toJoin 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 managedTo 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 skillsWhy
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.Equal Employment and
Opportunity Employer/Disabled/Veteran#LI-PH1#LI-RemoteContactIf you
forgot your password, you can click the Forgot Password button on
the Sign In screen to reset it.If you have any other questions
regarding the recruitment process please refer to our FAQs. In case
of technical difficulties with the website, please send an email to
careersite@philips.com.(Note: To ensure fairness and legal
compliance in our recruitment processes, only technical issues will
be monitored through the above inbox. Please do not submit resumes
or applications to this email, as they will not be reviewed. Only
applications received through the online application process will
be considered.)
Keywords: Philips, San Diego , Senior Manager, Design Quality Assurance Engineering (Software & Systems), Executive , San Diego, California
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