Director, Design and Software Quality Assurance
Location
Malvern, PA | United States
Job description
JOB DESCRIPTION
Job Title
Director, Design and Software Quality Assurance
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 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 .
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our 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 .
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 .
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.
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Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
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