Supplier Quality Specialist (Freelance)
EUMDR Supplier Quality Specialist
The Supplier Quality EUMDR Specialist reports to the Head of Supplier Quality - Markets, Quality & Regulatory, and will routinely interface/collaborate with multi-disciplined project team members, managers, and suppliers to effectively achieve compliance with European Union Medical Device Regulation (MDR) 2017/745. Due to scope of work primarily being to support the compliance with European Union Medical Device Regulatory (EU/MDR), this position will target a geographical location aligned with work hours in the Central European time zone. Periodic communication with external customers and 0%-10% travel is expected.
As a primary role, the Markets SQ EUMDR Specialist will provide Supplier Quality support to manage supplier interactions and ensure product compliance with the new European Union Medical Device Regulatory (EU/MDR) requirements for 3rd Party products. As an expanded role, the Markets SQE may participate in global supplier quality functions, such as supplier audits and SCAR management, provided the training and competency.
The candidate will have demonstrated experience with supplier quality engineering concepts, including, but not limited to: purchasing control, supplier qualification, supplier auditing, and continual improvement. The candidate must be able to perform core responsibilities with minimal supervision.
- Support the supplier quality processes, in conformance with the Philips PEPF framework / PQMS according to policies and procedures which comply with regulations and external standards, including software regulations, risk management, and change control per European Union Medical Device Regulations (EU MDR), ISO 13485 & ISO 14971, and other regulatory standards.
- Collaborates with Supplier Quality Assurance to ensure effective implementation of procedures, processes, and practices which relate with supplier qualification and 3rd Party product risk assessments.
- Supports implementation of EU MDR requirements affecting 3rd Party Product integrations into catalog.
- Manage pertinent Product Risk Assessment activities and communication as required for compatibility assessments.
- Ensure documents and associated files are provided, and completed PRA records are maintained and stored.
- Produces and completes Supplier Quality Engineering tasks supporting 3rd Party products (medical, non-medical) and services in Markets
- Review supplier conformance to Verification Inspection Plans
- Communicates with technical specialists and BG personnel to ensure product compatibility support and evaluation of risks (strategic, operational, compliance) related to 3rd Party product introductions.
- Bachelor's degree in engineering, science or business discipline.
- Must be able to communicate verbally and in writing, in English.
- Understanding of regulated industries and working knowledge of EU MDR, ISO 13485, EN 60601; and other international regulatory requirements for importation from EU.
- Experience with other international regulatory (i.e. GMP/QSR, Canadian Medical Device regulations) requirements is a plus.
- At least 3-years total industry experience with minimum 2 years of related experience in a medical device or regulated industry.
- Minimum of 2 years of product risk management experience. Ability to review medical product risk file elements per EU Medical Device Directives (MDDs), as well as the new MDR. Experience with ISO 14971 requirements is preferred.
- Familiarity and understanding of CE marking safety and essential performance requirements, including electromagnetic compatibility of Medical Electrical Equipment and Systems per EN 60601-1.
- Familiarity with European Database for Medical Devices? Unique Device Identification Database (EUDAMED) and FDA?s Global Unique Device Identification Database (GUDID) labeling requirements, such as Instructions for Use (IFUs) and product and device label identifiers, including requirements for licensed EU representatives for business outside the EU.
- Oral and verbal communication skills to work in teams, with expectations to contribute to Supplier Quality initiatives.
- Experienced technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity.
- Previous experience with Microsoft Office, Microsoft SharePoint is required.
- Ability to work cross functionally, working collaboratively across all parts of the organization.