Director, Quality & ComplianceJob Description
In this role, you have the opportunity to
We are looking for a strong leader to lead all aspects of quality compliance and design assurance operations for the Rancho Cordova site and associate QMS within Philips Image Guided Therapy Devices. The challenge is to ensure quality compliance, help integrate a fast growing business in the IGTD corporate structure, while enabling market launches and growth. For this you will need excellent influencing skills, in-depth knowledge of relevant Quality Assurance practices, a working knowledge of the regulatory context and understanding of design controls in a medical device’s environment.
You are the main interface between the QA/DAE team and business management. In this role, you would become the management representative and local quality system owner. You facilitate meeting business goals in a compliant manner and you understand how quality policies and business processes interact. You work closely with Regulatory Affairs, Product Development, Clinical, Operations, Service, and Marketing & Sales.
You are responsible for
- Maintaining a talented team that will support design assurance and quality compliance
- Support quality system integration activities within IGTD and broader Philips
- Lead site/QMS quality improvement and integration plans.
- Lead and coach the existing quality team (Design Assurance, document control, training, CAPA)
- Collaborate with other functions and departments on QA related aspects.
- Ensure released products are developed, manufactured, distributed and serviced at the right quality levels, in compliance with relevant regulations and Philips policies.
- Be an ‘ambassador’ for quality assurance and drive quality awareness and improvement.
- Compliance, effectiveness and efficiency of the QMS and its operations.
- Collaborate with Business and Q&R Management to establish strategic plans and objectives
- Establish and supervise quality objectives
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.
- You are a hands-on leader, leading by example, coaching and guiding the Quality team.
- You are responsible for compliance of the Quality Management System (QMS) with relevant standards and regulations.
- Bachelor/ Master’s degree with at least 10 years relevant experience in Quality
- Background in a Medical Devices or Pharma is required
- Combination Products experience is preferred
- Experience in maintaining compliant Quality Management Systems
- Experience with design controls in med device/pharma environment is required.
- Experience with manufacturing quality control and quality engineering
- Practical knowledge of medical European and US standards and regulations
- Consistent track record in integration of corporate quality systems is a plus.
- Excellent verbal and written communication skills (English)
- Strong communication and influencing skills
In return, we offer you:
The opportunity to work in a growing business group and lead a newly developing quality team. This position will sit at the forefront of groundbreaking technology and lead the team to future success. You will help to build and craft the culture and develop the future team.