Senior Quality Assurance Manager

hace 4 semanas


Madrid, Madrid, España Https:Www.Pcrecruiter.NetSitemap A tiempo completo

Job Title: Senior Quality Assurance Manager

Job Summary:

We are seeking a highly experienced Senior Quality Assurance Manager to join our team at PCRecruiter. The successful candidate will be responsible for implementing a total quality culture in the company, ensuring full compliance with MDR, ISO 13485, and 9001 requirements.

Key Responsibilities:

  • Participate in the implementation of a total quality culture in the company.
  • Maintenance and Improvement of QMS including SOP and WI development.
  • Lead General Regulatory Audits and Approval Submissions.
  • Drive internal and supplier audits.
  • Coordinate and manage Management Meeting Review, including the maintenance of QA metrics (KPIs).
  • Management and monitoring of non-conformities and CAPAs.
  • Management of QMS SW validations.
  • Management, design, and performance of QA training.
  • Support in the management of budget of the Quality department.
  • Support the Engineering and Manufacturing department in Quality and Regulatory Aspects of operations management – Management of DCOs (Document Change Orders).
  • Management of suppliers' evaluation.
  • Regulatory Assurance – Requirements:
    • Maintenance of Regulatory Environment.
    • Participate in the preliminary work for FDA, CE, and other medical approval processes in collaboration with agents, approval bodies, and consultants/CROs.
    • Participate in the documentation for regulatory approval bodies and consultants.
    • Coordinate Risk Assessment and Analysis throughout QMS and Product Development/Manufacturing.
    • Support V&V activities.
    • Support Clinical Investigations Submission to NCA and ECs.

Requirements:

  • Experience in the HealthCare Sector (> 3/5 years).
  • Trainee experience in Quality Assurance, Quality Control.
  • Thorough knowledge of ISO 13485:2016, ISO 9001:2015, and relevant Medical ISO standards, MDR, along US-FDA Regulations.
  • Knowledge in GMP, GLP, GDP.
  • Education and experience: Industrial Engineering, Science, or Medical Device Technology Degree.
  • English (ALTE-4 or higher).
  • Prior experience in the medical device industry.
  • Certified Quality Auditor (preferably).


  • Madrid, Madrid, España Takeda A tiempo completo

    Job SummaryAs a Senior Quality Assurance Manager at Takeda, you will play a pivotal role in ensuring the highest standards of quality in our medicinal products. Located in Madrid, Spain, this full-time position offers a unique opportunity to drive excellence and contribute to better health outcomes for patients worldwide.


  • Madrid, Madrid, España Roche A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Manager to join our team at Roche.As a Senior Quality Assurance Manager, you will be responsible for ensuring the reliability and compliance of Roche's regulatory and critical IT systems.You will lead the IT Quality strategies and evolve Roche Informatics as an organization, leveraging...


  • Madrid, Madrid, España Network Scientific Ltd. A tiempo completo

    Quality Assurance Manager RoleWe are currently recruiting for a Quality Assurance Manager to join our team at Network Scientific Ltd. in the UK. As a Quality Assurance Manager, you will be responsible for three direct reports and supporting the site QPs with batch releases.This is a site leadership position and you will work closely with the operational...


  • Madrid, Madrid, España Gilead Sciences, Inc. A tiempo completo

    Job SummaryThe Senior Quality Assurance Manager will be responsible for ensuring the quality of our apheresis and treatment centers. This includes performing selection audits, qualifying and monitoring compliance to qualification requirements. The ideal candidate will have a strong background in quality assurance and experience working in a medical or...

  • Quality Assurance Manager

    hace 4 semanas


    Madrid, Madrid, España Huel A tiempo completo

    Quality Assurance ManagerWe are seeking a highly skilled Quality Assurance Manager to join our team at Huel. As a Quality Assurance Manager, you will be responsible for ensuring the safety and quality of our products, working closely with our manufacturing and supply chain partners to maintain high standards.Key Responsibilities:Develop and implement quality...


  • Madrid, Madrid, España Boston Scientific A tiempo completo

    Boston Scientific is a global leader in medical science with over 40 years of experience. Our mission is to advance science for life by transforming lives through innovative medical solutions.We are currently seeking a Senior Quality Assurance Manager to join our team in EMEA. As a key member of our Magellan program, you will play a crucial role in assessing...


  • Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Senior Quality Assurance SpecialistJohnson & Johnson is seeking a Senior Quality Assurance Specialist to support the global quality mission. The successful candidate will serve as a point of contact for quality and compliance aspects for World Wide DePuy Synthes Service Centers.Key Responsibilities:Ensure general compliance support for consistent and correct...


  • Madrid, Madrid, España Nn Group A tiempo completo

    **Job Title:** Senior Quality Assurance SpecialistWe are seeking a skilled Senior Quality Assurance Specialist to join our team at Nn Group. As a key member of our QA team, you will be responsible for ensuring the high quality of our technology solutions.Key Responsibilities:Identify potential malfunctions and determine their importance levelMonitor the...


  • Madrid, Madrid, España Merck A tiempo completo

    **Job Summary**Merck is seeking a highly experienced Senior Quality Assurance Manager to lead our Contract Testing Labs (CTLs) team. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of quality in our CTLs operations.**About the Role**The Senior Quality Assurance Manager will oversee the...


  • Madrid, Madrid, España Alk-Abelló AS A tiempo completo

    Job Title: Senior Quality Assurance SpecialistAbout the Role:Alk-Abelló A/S is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a Senior Quality Assurance Specialist, you will be responsible for providing support for and being directly responsible for a range of Quality Assurance functions. This position will contribute to...


  • Madrid, Madrid, España Gilead Sciences, Inc. A tiempo completo

    Job SummaryThe Senior Quality Assurance Manager will be part of the European Product Distribution and Quality team, responsible for ensuring the quality of our products and services. The role requires the ability to travel nationally and internationally up to 50%.Key ResponsibilitiesPerform selection audits, qualify and monitor compliance to qualification...


  • Madrid, Madrid, España Jones Lang Lasalle Incorporated A tiempo completo

    Job Title: Senior Quality Assurance SpecialistAbout the Role:We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Jones Lang Lasalle Incorporated. As a key member of our Quality Assurance team, you will be responsible for ensuring the highest quality of our software products.Key Responsibilities:Conduct thorough testing of...

  • Quality Assurance Manager

    hace 4 semanas


    Madrid, Madrid, España Huel A tiempo completo

    Role OverviewWe are seeking a highly skilled Quality Assurance Manager to join our team at Huel. As a Quality Assurance Manager, you will play a critical role in ensuring the safety and quality of our products, including Powders, Bars, and Ready-to-drink products.Key ResponsibilitiesWork closely with our US manufacturing and ingredients supply base to ensure...


  • Madrid, Madrid, España Dac Beachcroft Llp A tiempo completo

    Company OverviewDAC Beachcroft LLP, a leading law firm, is seeking an experienced Senior Quality Assurance Specialist to join their Quality Team. With a strong focus on quality and risk management, the successful candidate will play a crucial role in ensuring compliance with policies, controls, and procedures across the organization.Job SummaryWe are...

  • Quality Assurance Manager

    hace 4 semanas


    Madrid, Madrid, España Marriott International, Inc A tiempo completo

    Job Summary:The Quality Assurance Manager is responsible for implementing quality assurance processes that meet the company's mission and brand standards, target customer needs, ensure employee satisfaction, and focus on continuous improvement at the property level. This position champions the Quality function and builds support for change.Key...


  • Madrid, Madrid, España Quirónprevención A tiempo completo

    We are seeking a Senior Quality Assurance Specialist to join our team at Quirónprevención. The successful candidate will be responsible for ensuring the quality of our wind farm projects in Romania.Requirements:5+ years of experience in quality assurance or a related fieldTechnical background with a Bachelor's and/or Master's degree in engineeringFluent...


  • Madrid, Madrid, España Take-Two Interactive Software Inc A tiempo completo

    Job DescriptionWe are seeking an experienced Senior QA Manager to join our team at Take-Two Interactive Software Inc. The ideal candidate will have a strong background in quality assurance, with experience managing teams and projects.About the RoleLead a team of QA Testers to ensure high-quality game developmentDevelop and implement quality assurance...


  • Madrid, Madrid, España Quirónprevención A tiempo completo

    We are seeking a highly skilled Quality Assurance Manager to join our team at Quirónprevención.The ideal candidate will have a strong background in quality management and a passion for renewable energy. As a Quality Assurance Manager, you will be responsible for ensuring the highest standards of quality in our wind farm projects.Key...

  • Quality Assurance Manager

    hace 4 semanas


    Madrid, Madrid, España Gleeds A tiempo completo

    About the RoleWe are seeking a Quality Assurance Manager to join our team at Gleeds. As a Quality Assurance Manager, you will be responsible for conducting internal audits across our operations in Spain, Portugal, and Italy, ensuring compliance with ISO 9001 and ISO 27001 standards.Key Responsibilities:Ensure all systems and procedures meet ISO 9001 / ISO...


  • Madrid, Madrid, España Grooo A tiempo completo

    About the RoleWe are seeking a highly skilled and experienced Quality Assurance professional to lead our Validation and Verification team at Grooo. The ideal candidate will have a strong background in quality engineering, with a focus on cameras and sensors.Key Responsibilities:Develop and implement comprehensive Validation and Verification strategies to...