About the Role: We are looking for a Regional Quality Assurance Engineer (f/m/d) to join the EMEA Regional Quality Assurance team to support our operations in the EMEA region. In this role, you will be responsible for planning and coordinating all quality related activities associated with our Economic Operators and the planning and support of Internal and External Audits to maintain our ISO13485 certifications in the region including the creation of Change Orders, Nonconformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs) to maintain compliance and improve existing processes as we implement a new electronic Quality Management System and provide general support to other RQAs in support of regional quality activities as necessary.
This position will be located at our facility in Barcelona, Spain, with work from home days possible as part of a hybrid arrangement, depending upon the responsibilities of the role and business needs.
Responsibilities:
Design, develop, improvement and sustainment of compliant processes and procedures in support of global quality operations while involving the appropriate functional groups in communications and decision making.
Initiate NCR/CAPA activities as required, including identification of root cause, action planning and post implementation effectiveness checks.
Have an understanding of regional regulatory needs and requirements, provide input to gap analysis of regulation updates (e.g. ISO 13485, EU MDR, etc.).
Support and perform internal and external audits as appropriate (e.g. 3PL, distributors, importers, OEMs, suppliers).
Delivery of appropriate Quality System training to MPD associates and/or third-party employees according to business needs.
Initiate change documentation and prepare quality reports and presentations, including input to Trend Review Boards and Management Review.
Coordinate with and provide QA support to other regional and global functions (e.g. Distribution and Logistics, Customer Service, Sales Contracts, Regulatory, Product Surveillance Group, Labelling, Field Action Teams, etc.).
Assist in the development and execution of global and regional quality objectives and resource plans.
Required Qualifications:
Bachelors or equivalent degree.
Minimum 4 years medical device or other life-science industry experience in developing, implementing and maintaining quality systems.
Demonstrated strong technical capability.
Effective interpersonal skills with experience collaborating effectively across functions and establishing key relationships.
Knowledge of ISO 13485 and EU MDR.
Ability to multitask, prioritize and meet deadlines.
Ability to work alone or as part of a diverse team.
Fluent in English with strong verbal and written communication skills.
Strong organisational skills and detail oriented while being flexible and able to adapt to changing priorities.
Desired Qualifications:
QA experience in Manufacturing, Distribution or Customer Service organisations, and Economic operator processes.
Auditing skills and experience.
Certified Quality Auditor.
Hybrid Working Arrangements are permitted with appropriate approval and compliance with Gore's policy.
What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits.
We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact.
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