Design Assurance Quality Engineer
- San Diego, CA
Design Assurance Quality Engineer
In this role, you have the opportunity to
As a Design Assurance Quality Engineer, the primary responsibility will be to work within the Quality Management System (QMS) to support the Design Assurance process during the development of new medical devices. Under the direction of Design Assurance Management, you will apply company policy and procedures as well as regulatory requirements to analyze situations or data and draw conclusions. Assignments will include creating, reviewing and updating documents, auditing Design History Files and actively participating as a core team member of new product development teams including design input generation, risk management, detailed design, verification and validation activities and design transfer to production.
You are responsible for
- Understand the processes and intent of all aspects of the QMS related to Design Controls
- Create and update new product risk management deliverables including Risk Management Files, Risk Management Plans, Use FMEAs, Design FMEAs and Risk Management Reports
- Support broader Design Assurance initiatives such as EU MDR readiness and Risk Management Remediation
- Using engineering principles, analyze situations or data to identify gaps between project work product and the QMS
- Provide Design Assurance review of deliverables to assess for compliance with internal and external requirements
- Reviewing test data and ensuring the required confidence and reliability is achieved using statistical expertise
- Creating biological test strategies and assessing biological risks for design and process changes
- Creating biocompatibility test protocols, overseeing biocompatibility testing and writing biocompatibility test reports
- Developing a strategy for chemical characterization testing, overseeing chemical characterization analysis and writing chemical characterization report
- Work with product development teams to ensure safe and effective product designs
- Collaborate with R&D to ensure component drawings and specifications are adequate to convey design requirements and that critical aspects of the design are indicated and able to be assessed quantitatively or qualitatively
- Develop familiarity with our products and analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles
- Lead Corrective and Preventive Actions (CAPA)
- Lead distributed product impact analysis activities
- Lead QMS continuous improvement projects as they relate to Design Assurance and Complaint Review Board Process
- Drive for and lead procedural creation, alignment and clarifications
- Support alignment to Philips PDLM framework
- Support the rollout of PILS software tools
- Build stable relationships internally across Design Assurance team and within project core teams
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.
- Working knowledge of the new product design and development in a regulated environment; preferably medical device
- Working knowledge of the application of risk management; preferably to medical device development
- Excellent organizational and interpersonal skills working in a cross-functional teams.
- Ability to organize and prioritize workflow across multiple projects in order to meet established time frames and schedules
- 3+ years experience in Quality Assurance, including Quality systems, standards, metrics, and tools.
- 3+ years experience in medical device industry.
- Working knowledge of medical device regulations (FDA 21CFR80.820, FDA 21 CRF Part 11, ISO13485, ISO10993, ISO14971, ISO10555)
- Supporting internal and external audits
- Proficiency with the following software programs - Microsoft Excel, PowerPoint, and Word and Visio
- Experience working with PLM systems (e.g. Windchill), statistical software, defect tracking tools (e.g. ClearQuest), complaint management tools
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.
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