Regional Quality Assurance Specialist

hace 4 días

Madrid, Madrid, España W. L. Gore & Associates, Inc A tiempo completo
About the Role:

We are seeking a highly skilled Regional Quality Assurance Specialist to join our EMEA Regional Quality Assurance team. 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.

Key Responsibilities:

  • Process Development and Improvement: Design, develop, and sustain compliant processes and procedures in support of global quality operations while involving the appropriate functional groups in communications and decision making.
  • NCR/CAPA Activities: Initiate NCR/CAPA activities as required, including identification of root cause, action planning, and post-implementation effectiveness checks.
  • Regulatory Compliance: Have an understanding of regional regulatory needs and requirements, provide input to gap analysis of regulation updates (e.g. ISO 13485, EU MDR, etc.).
  • Audit Support: Support and perform internal and external audits as appropriate (e.g. 3PL, distributors, importers, OEMs, suppliers).
  • Quality System Training: Delivery of appropriate Quality System training to associates and/or third-party employees according to business needs.
  • Quality Reporting: Initiate change documentation and prepare quality reports and presentations, including input to Trend Review Boards and Management Review.
  • Collaboration and Communication: 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.).
  • Quality Objectives and Resource Planning: Assist in the development and execution of global and regional quality objectives and resource plans.

Required Qualifications:

  • At least 4 years of experience in the medical device or life-science industry 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 organizational skills and detail-oriented while being flexible and able to adapt to changing priorities.

Desired Qualifications:

  • QA experience in Manufacturing, Distribution, or Customer Service organizations, and Economic operator processes.
  • Auditing skills and experience.
  • Certified Quality Auditor.

What We Offer:

We provide a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow. Our benefits offer choice and flexibility and promote overall well-being. We also provide a distinctive Associate Stock Ownership Plan and potential opportunities for profit-sharing.

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 our 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.

We are an equal opportunity employer and 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.

  • Regional Quality Assurance Specialist

    hace 2 días

    Madrid, Madrid, España W. L. Gore & Associates, Inc A tiempo completo

    **Job Summary**W. L. Gore & Associates, Inc is seeking a highly skilled Regional Quality Assurance Engineer to join our EMEA Regional Quality Assurance team. As a key member of our team, 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...

  • Regional Quality Assurance Specialist

    hace 3 días

    Madrid, Madrid, España W. L. Gore & Associates, Inc A tiempo completo

    **Job Summary**W. L. Gore & Associates, Inc is seeking a highly skilled Regional Quality Assurance Engineer to join our EMEA Regional Quality Assurance team. As a key member of our team, 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...

  • Quality Assurance Specialist

    hace 7 días

    Madrid, Madrid, España Cummins Quality A tiempo completo

    Job SummaryCummins Quality is seeking a highly skilled Quality Assurance Specialist to join our team in San Fernando de Henares, Spain. As a key member of our Quality department, you will be responsible for ensuring the highest quality standards in our supply chain.Key ResponsibilitiesAchieve Quality Certifications: Utilize your certifications and industry...

  • Quality Assurance Specialist

    hace 6 días

    Madrid, Madrid, España Cummins Quality A tiempo completo

    Job SummaryCummins Quality is seeking a highly skilled Quality Assurance Specialist to join our team in San Fernando de Henares, Spain. As a key member of our Quality department, you will be responsible for ensuring the highest quality standards in our supply chain.Key ResponsibilitiesAchieve Quality Certifications: Utilize your certifications and industry...

  • Quality Assurance Specialist

    hace 6 días

    Madrid, Madrid, España Worldwide Recruitment Solutions A tiempo completo

    Job Title: Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Worldwide Recruitment Solutions. As a Quality Assurance Specialist, you will be responsible for implementing and maintaining an overall Quality Management System for our clients' projects.Key Responsibilities:Implement and...

  • Quality Assurance Specialist

    hace 6 días

    Madrid, Madrid, España Worldwide Recruitment Solutions A tiempo completo

    Job Title: Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Worldwide Recruitment Solutions. As a Quality Assurance Specialist, you will be responsible for implementing and maintaining an overall Quality Management System for our clients' projects.Key Responsibilities:Implement and...

  • Quality Assurance Specialist

    hace 4 días

    Madrid Centro, Madrid, España QCP Capital Pte. Ltd. A tiempo completo

    Job Description**Job Title:** Quality Assurance Specialist**Company:** QCP Capital Pte. Ltd.**Job Summary:** We are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our projects and ensuring compliance with our quality management system.Key...

  • Quality Assurance Specialist

    hace 4 días

    Madrid Centro, Madrid, España QCP Capital Pte. Ltd. A tiempo completo

    Job Description**Job Title:** Quality Assurance Specialist**Company:** QCP Capital Pte. Ltd.**Job Summary:** We are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our projects and ensuring compliance with our quality management system.Key...

  • Quality Assurance Specialist

    hace 4 días

    Madrid, Madrid, España Takeda A tiempo completo

    Job DescriptionJob Title: Quality Assurance SpecialistJob Summary:Takeda is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services, and for maintaining compliance with regulatory requirements.Key Responsibilities:Develop and...

  • Quality Assurance Specialist

    hace 3 días

    Madrid, Madrid, España Takeda A tiempo completo

    Job DescriptionJob Title: Quality Assurance SpecialistJob Summary:Takeda is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services, and for maintaining compliance with regulatory requirements.Key Responsibilities:Develop and...

  • Quality Assurance Specialist

    hace 6 días

    Madrid Centro, Madrid, España QCP Capital Pte. Ltd. A tiempo completo

    Job Description**Job Title:** Quality Assurance Specialist**Job Summary:** We are seeking a highly skilled Quality Assurance Specialist to join our team at QCP Capital Pte. Ltd. The successful candidate will be responsible for ensuring the quality of our projects and ensuring compliance with our quality management system.Key Responsibilities:Quality...

  • Quality Assurance Specialist

    hace 7 días

    Madrid Centro, Madrid, España QCP Capital Pte. Ltd. A tiempo completo

    Job Description**Job Title:** Quality Assurance Specialist**Job Summary:** We are seeking a highly skilled Quality Assurance Specialist to join our team at QCP Capital Pte. Ltd. The successful candidate will be responsible for ensuring the quality of our projects and ensuring compliance with our quality management system.Key Responsibilities:Quality...

  • Quality Assurance Specialist

    hace 4 días

    Madrid Centro, Madrid, España QCP Capital Pte. Ltd. A tiempo completo

    Job Description**Job Title:** Quality Assurance Specialist**Job Summary:** We are seeking a highly skilled Quality Assurance Specialist to join our team at QCP Capital Pte. Ltd. The successful candidate will be responsible for ensuring the quality of our projects and ensuring compliance with our quality management system.Key Responsibilities:Quality...

  • Quality Assurance Specialist

    hace 4 días

    Madrid Centro, Madrid, España QCP Capital Pte. Ltd. A tiempo completo

    Job Description**Job Title:** Quality Assurance Specialist**Job Summary:** We are seeking a highly skilled Quality Assurance Specialist to join our team at QCP Capital Pte. Ltd. The successful candidate will be responsible for ensuring the quality of our projects and ensuring compliance with our quality management system.Key Responsibilities:Quality...

  • Quality Assurance Specialist

    hace 4 días

    Madrid, Madrid, España Gestamp A tiempo completo

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Gestamp. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key ResponsibilitiesQuality Strategy Development: Develop and deploy quality strategies for quotation and project phases, ensuring...

  • Quality Assurance Specialist

    hace 4 días

    Madrid, Madrid, España Gestamp A tiempo completo

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Gestamp. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key ResponsibilitiesQuality Strategy Development: Develop and deploy quality strategies for quotation and project phases, ensuring...

  • Quality Assurance Specialist

    hace 4 días

    Madrid Centro, Madrid, España QCP Capital Pte. Ltd. A tiempo completo

    Job Description**Job Title:** Quality Assurance Specialist**Company:** QCP Capital Pte. Ltd.**Job Summary:** We are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our projects and ensuring compliance with our quality management systems.Key...

  • Quality Assurance Specialist

    hace 4 días

    Madrid Centro, Madrid, España QCP Capital Pte. Ltd. A tiempo completo

    Job Description**Job Title:** Quality Assurance Specialist**Company:** QCP Capital Pte. Ltd.**Job Summary:** We are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our projects and ensuring compliance with our quality management systems.Key...

  • Quality Assurance Specialist

    hace 6 días

    Madrid, Madrid, España Worldwide Recruitment Solutions (Wrs) A tiempo completo

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Worldwide Recruitment Solutions (Wrs). As a Quality Assurance Specialist, you will be responsible for implementing and maintaining a comprehensive Quality Management System for our clients.Key Responsibilities:Develop and implement quality management systems to...

  • Quality Assurance Specialist

    hace 6 días

    Madrid, Madrid, España Worldwide Recruitment Solutions (Wrs) A tiempo completo

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Worldwide Recruitment Solutions (Wrs). As a Quality Assurance Specialist, you will be responsible for implementing and maintaining a comprehensive Quality Management System for our clients.Key Responsibilities:Develop and implement quality management systems to...