Director, Design and Software Quality Assurance
Company: Philips
Location: Bend
Posted on: April 28, 2024
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Job Description:
Director, Design and Software Quality Assurance (U.S. hub
based)
The Director, Design and Software Quality Assurance is responsible
for ensuring all functions of Design Assurance & Software Quality
Engineering are in compliance to all applicable internal, domestic
and international quality regulations (US 21 CFR 820 (QSR), ISO
13485, ISO 14971, etc.) This position is granted the authority to
take any actions required to fulfill the scope, duties, and
responsibilities of this position.
Your role:
Provide Risk Management and Design Assurance/Quality Engineer
leadership in direct support of medical device development. Provide
guidance for software product development under Design Controls and
Software Development Life Cycle process; User and Product
requirements, Functional Specifications, Configuration Management,
Design Verification, Design Validation, Risk Management, Design
Reviews, Pre- and Post-Market Software changes and Defect Tracking
and Management.
Manage and develop the Design Assurance/Risk Management Quality
Engineering department including Pre and Post Market activities.
Guide and support process and software validation policy and
procedures. Identify the opportunities for continuous improvement
of the Quality Systems, including Software Development Life Cycle
process and document generation. Provide guidance and decisions on
product development and software product development activities to
ensure continued compliance with internal procedures, and
applicable regulatory and international standards.
Assess software product regulations and standards impact to meet
global requirements. Work closely with New Product Introduction
teams to meet software and hardware compliance requirements on
schedule. Ensure all necessary compliance documentation is current
and available upon request.
Manage the pre & post-production Design Assurance/Quality
Engineering activities including Risk Management and Sustaining
Engineering. Support development and execution of Operations,
Supplier Quality, and Non-Product Software Validations thru design
controls. Identify opportunities to proactively assure compliance
to all applicable internal, domestic and international quality
regulations, 21 CFR 820 (QSR), ISO 13485, ISO14971, etc.
Support the definition and execution of R&D driven design
transfer activities. Champion quality improvement initiatives.
Drive best practices within the organization. Partner with R&D
and interact successfully with various departments within the
organization.
You're the right fit if:
You've acquired 10+ years of experience in quality engineering,
technical project management, risk management, and/or quality
assurance roles of increasing responsibility, impact, and scope
within a manufacturing/new product development/medical device
supporting environment.
Your skills include knowledge of 21 CFR 820, ISO 13485 & 14971, and
demonstrated background working with a combination of risk
management, design assurance, quality engineering, software product
development, software development life cycles, design verification
& validations, and leadership over a team of direct reports within
these functions.
You have a bachelor's degree or higher in an Engineering or related
field.
You must be able to successfully perform the following minimum
Physical, Cognitive and Environmental job requirements with or
without accommodation for this Office/Remote
(https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements)
position.
You have demonstrated and impactful experience in risk management,
product development, product and process validation, software
validation (device & quality system support), test method
validation, and statistics.
About Philips
We are a health technology company. We built our entire company
around the belief that every human matters, and we won't stop until
everybody everywhere has access to the quality healthcare that we
all deserve. Do the work of your life to help improve the lives of
others.
Learn more about our business
(https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history.
(https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose.
(https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Read more about our employee benefits
(https://www.careers.philips.com/na/en/best-employee-benefits)
.
If you're interested in this role and have many, but not all, of
the experiences needed, we encourage you to apply. You may still be
the right candidate for this or other opportunities at Philips.
Learn more about our commitment to diversity and inclusion here
(https://www.careers.philips.com/global/en/diversity-and-inclusion)
.
Philips Transparency Details
The pay range for this position is $128,050 to $264,768, annually.
The actual base pay offered may vary depending on multiple factors
including job-related knowledge/skills, experience, business needs,
geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus,
sales commission or long-term incentives may be offered. Employees
are eligible to participate in our comprehensive Philips Total
Rewards benefits program, which includes a generous PTO, 401k (up
to 7% match), HSA (with company contribution), stock purchase plan,
education reimbursement and much more. Details about our benefits
can be found here
(https://www.careers.philips.com/na/en/best-employee-benefits)
.
At Philips, it is not typical for an individual to be hired at or
near the top end of the range for their role and compensation
decisions are dependent upon the facts and circumstances of each
case.
Additional Information
US work authorization is a precondition of employment. The company
will not consider candidates who require sponsorship for a
work-authorized visa, now or in the future.
Company relocation benefits will not be provided for this position.
For this position, you must reside in or within commuting distance
to posted Hub location.
Philips is an Equal Employment and Opportunity
Employer/Disabled/Veteran and maintains a drug-free workplace.
#LI-PH1
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
Keywords: Philips, Bend , Director, Design and Software Quality Assurance, Executive , Bend, Oregon
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