Job Title
Quality Compliance Specialist
Job Description
Quality Compliance Specialist
Support business and site level aspects of the quality management system for the Philips Image Guided Therapy Devices business. You will support sites within this business in continuous maintenance and improvement of the Quality Management System and its subsystems.
You are responsible for
Assisting Quality Manager (as auditee) for Audits (internal & external)
Quality CAPA Owner/Approver for all CAPAs
Quality Facilitator/Approver for all NCRs
Assisting the EC MDD Authorized Rep with mandatory vigilance reporting & FSCAs to Notified Bodies, Competent Authorities and Customers within the EU
Implementing and maintaining the Quality Management System according to the European and International regulations/guidelines; ISO 13485:2016, FDA 21CFR 820, EUMDR 2017/745
Updating (incl. writing of) of SOPs/WIs to ensure the highest compliance to our standards
Quality approver of QMS changes in lieu of the Quality Manager
Maintaining (in view of audit readiness) all QMS documents (& records) in relation to operational & commercial processes (incl. field sales, Customer Service and Order Management etc.)
Ensuring that the Complaint Device Handling is done in a timely and orderly manner
Updating/maintaining the Complaint handling database/SAP searches to aid complaint investigations
Supporting the Quality and Operations Team with the implementation of processes – incl. System Installations
Supporting the Operations Team with the physical distribution of our products (incl. logistics)
Maintaining LMS Training tool for International (incl. aiding people managers in annual reviews etc.)
Assisting the Quality Manager and Team with the onboarding processes of new hires
Support and sometimes execute change notices within the Document Controls system (Windchill) ensuring appropriateness and effectiveness.
Escalate areas of non-compliance, risk and/or potential improvement to Management and develop plans for appropriate action to address causes of deficiencies. Identify and investigate potential trends for improvement initiatives.
Maintaining the highest level of compliance (in the form of training sessions) for the employees
You are a part of
The international Quality team for our Image Guided Therapy Devices department and support any IGTD site as needed. We are a very diverse and dynamic team, located in Best (NL) and USA.
To succeed in this role, you’ll need a customer-first attitude and the following
Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
You’ve acquired 5+ years of experience in Quality Management Systems, Regulatory Compliance, Auditing with medical device or a regulated industry, preferred.
Your skills include proficiency in of ISO 9001, ISO 13485, FDA CRF 21 part 820 and Good Manufacturing Practices (GMP).
Fluent in English, any other language is an advantage
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
This is an office role.
Compensation & benefits for Best location (NL)
Doing meaningful work should come with fair, transparent rewards. The base salary range for this role is €61,185.00 –€101,975.82 . We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations.
This role is eligible for 3% bonus with your rewards linked to your KPIs and company results . We’ll share the full approach with you during the interview process, so you can make a clear, informed decision.
About Philips
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