Quality Engineer (Freelance)
Support venture teams with Quality Management System and Quality Assurance activities to bring innovative products to our customers.
Coach and support the venture's projects team to always do the right thing, first time right. This involves being a confident advisor on compliance and product quality related topics, in order to achieve timely releases of innovative products that deliver high quality to the lives they will improve.
You are responsible for
- Providing effective oversight of the QMS Change Control activities; and report status to the QMS and Quality Manager.
- Providing support to authors and (local) process owners in defining and producing lean Quality System documents and records; ensure proper quality of the content of documentation and records. Ensures availability/publishing and training of controlled documents.
- Providing effective oversight of the CAPA and Complaint Handling activities; and report status in the respective control boards.
- Providing support in quality related problem solving and root cause analysis during design and manufacturing to ensure that Product / System design meets quality and compliance standards and prevent reoccurrence of quality issues.
- Providing support to ensure internal and external audit readiness and support during those audits. If sufficiently qualified may perform internal audits.
- Perform incoming inspection and/or final release acceptance activities of products manufactured by contract manufacturers.
You are a part of
IGT-Innovation Q&R team. This team consists of various functions Quality and Regulatory and you will work closely with these functions based on specific projects. You will be part of the global Philips Q&R organization and will be reporting to the Q&R head of IGT Systems / Innovation.
A fast growing and innovative Quality Assurance/Quality Engineering team, within an ever-changing environment - constantly striving for improvements and exceeding internal and external stakeholder expectations.
To succeed in this role, you should have the following skills and experience
We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We're looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year. Specific skill requirements for this role include:
- Bachelor degree; with 4+ years' experience in the regulated medical industry.
- Understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, MDD/MDR and ISO 14971
- Demonstrated experience with (QMS) Document and Change Control
- Demonstrated experience with CAPA management and/or root cause investigations and defining appropriate corrective / preventive actions.
- Demonstrated experience with Compliant Handling.
- Have an understanding of the audit process. Having Lead Auditor certification for (EN) ISO 13485:2016 with additional qualification for MDSAP country regulations is a strong preference.
- Excellent English skills, written and speaking.