Manager, Sustaining Design Quality Assurance
In this role, you have the opportunity to
As a Manager of Sustaining Design Assurance, the primary responsibility will be to work within the Quality Management System (QMS) to support the Design Assurance process during the assessment and implementation of design changes to existing medical devices. You will apply company policy and procedures to work with supporting team members 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 lead of design change teams or supporting teammates who act as core team leads on design changes projects. Tasks on design change projects can include review of product requirements, risk management, detailed design, verification and validation activities and design transfer to production. The Manager of Sustaining Design Assurance will also update existing Work Instructions and play a role in creation of new Work Instructions.
You are responsible for
- Drive engagement within and develop Sustaining Design Assurance team members
- Ensure that sustaining projects are adequately staffed and supported
- Understand and implement processes and intent of all aspects of the QMS related to Design Controls
- Using engineering principles, analyze situations or data to identify gaps between project work and QMS
- Work with sustaining teams and other Design Assurance QEs to assure compliance to the QMS
- Develop mastery of 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) and QMS continuous improvement projects as they relate to Design Assurance and Complaint Review Board Process
- Have an understanding of shelf life and biocompatibility testing to create and facilitate creation of associated test procedures and reports
- Create and facilitate updates to product risk analyses and risk management files
- Develop and implement new and improved quality/compliant pre-market engineering methods, techniques and processes.
- Build stable relationships internally
To succeed in this role, you should have the following skills and experience
- B.S. degree in Science, Engineering or associated fields
- Must have organizational and interpersonal skills working in a cross-functional teams and managing direct reports
- Ability to organize and prioritize workflow and projects in order to meet established time frames and schedules
- 2+ years management experience of engineering or other technical role
- Knowledge of medical device regulations (FDA 21CFR80.820, ISO13485, ISO10993)
- Mastery of software programs - Microsoft Outlook, Excel, PowerPoint and Word
- 10+ years experience in Quality Assurance, including Quality systems, standards, metrics, and tools
- 6+ years experience in medical device industry
- Certified Quality Engineer (CQE)
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.
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 to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.
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