Quality Assurance Specialist

Becton Dickinson

Paterna

Presencial

EUR 55.000 - 59.000

Jornada completa

Hace 2 días
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Descripción de la vacante

Becton Dickinson is seeking a Quality Compliance Specialist to coordinate and execute the regional quality compliance program across EMEA, leading internal audits and supporting external audits to strengthen the Quality Management System.

The ideal candidate has a Life Sciences degree and 3–5 years in regulated QA/QMS roles, with strong knowledge of ISO 13485 and regulatory requirements. Fluency in English is required; travel within the EMEA region is expected.

Formación

  • Bachelor's degree in Life Sciences, Engineering, Quality Management, or a related discipline.
  • 3–5 years of experience in Quality Assurance, Quality Compliance, or Quality Systems within regulated industries (Medical Devices, Pharmaceutical, Biotechnology, or similar).
  • Experience planning and conducting internal audits.
  • Experience supporting external audits and regulatory inspections.
  • Experience preparing management review materials and quality metrics analysis.
  • Fluent in English; additional European languages are an advantage.

Responsabilidades

  • Develop and maintain the annual EMEA internal audit program based on risk, regulatory requirements, and business priorities.
  • Plan, conduct, document, and report internal audits across EMEA locations and functions.
  • Monitor audit findings and support site management in the timely implementation and closure of corrective and preventive actions (CAPAs).
  • Coordinate and support external audits, including notified body, certification body, customer, and regulatory inspections.
  • Prepare and consolidate Management Review inputs and reports, ensuring accuracy, completeness, and timely delivery.
  • Analyze quality metrics and trends to support Management Review discussions and decision-making.
  • Support maintenance and continuous improvement of the Quality Management System in accordance with applicable regulations and standards.
  • Provide guidance to functions and sites on quality compliance requirements, audit readiness, and best practices.
  • Support Quality activities across the region, including CAPA management, quality risk management, document control, change management, training compliance, and quality reporting, as required.
  • Collaborate with regional and global Quality teams to ensure alignment of compliance initiatives and quality objectives.
  • Promote a culture of quality, compliance, and continuous improvement throughout the organization.

Conocimientos

Quality Assurance
Quality Compliance
Internal Audits
Regulatory Inspections
QMS Knowledge

Educación

Bachelor's degree in Life Sciences or related
Certified Internal Auditor

Herramientas

ISO 13485
FDA QSR

Descripción del empleo

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

The Quality Compliance Specialist is responsible for coordinating and executing the regional Quality Compliance program across EMEA. This role leads the planning and performance of internal audits, supports external regulatory and certification audits, prepares Management Review reports, and contributes to the effective operation and continuous improvement of the Quality Management System (QMS) throughout the region.

Key Responsibilities
  • Develop and maintain the annual EMEA internal audit program based on risk, regulatory requirements, and business priorities.
  • Plan, conduct, document, and report internal audits across EMEA locations and functions.
  • Monitor audit findings and support site management in the timely implementation and closure of corrective and preventive actions (CAPAs).
  • Coordinate and support external audits, including notified body, certification body, customer, and regulatory inspections.
  • Prepare and consolidate Management Review inputs and reports, ensuring accuracy, completeness, and timely delivery.
  • Analyze quality metrics and trends to support Management Review discussions and decision-making.
  • Support maintenance and continuous improvement of the Quality Management System in accordance with applicable regulations and standards.
  • Provide guidance to functions and sites on quality compliance requirements, audit readiness, and best practices.
  • Support Quality activities across the region, including CAPA management, quality risk management, document control, change management, training compliance, and quality reporting, as required.
  • Collaborate with regional and global Quality teams to ensure alignment of compliance initiatives and quality objectives.
  • Promote a culture of quality, compliance, and continuous improvement throughout the organization.
About you
  • Bachelor's degree in Life Sciences, Engineering, Quality Management, or a related discipline.
  • Minimum 3–5 years of experience in Quality Assurance, Quality Compliance, or Quality Systems within a regulated industry (Medical Devices, Pharmaceutical, Biotechnology, or similar).
  • Experience planning and conducting internal audits.
  • Experience supporting external audits and regulatory inspections.
  • Experience preparing management review materials and quality metrics analysis.
  • Strong knowledge of Quality Management Systems and applicable regulations and standards (e.g., ISO 13485, FDA QSR, MDR, or equivalent).
  • Certified Internal Auditor qualification is preferred.
  • Fluent in English; additional European languages are an advantage.
  • Ability to travel within the EMEA region as required.
Salary range for this role

55000€ - 59000€

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers.

Benefits and Compensation

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program.

We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.

You can learn more on our career site under "Our Commitment to You".

Our salary or hourly rate ranges reward associates fairly and competitively.

We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully.

The salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information €37,700.00 - €60,350.00 EUR Annual BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

Equal Opportunity Employer

Becton, Dickinson, and Company is an Equal Opportunity Employer.

We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location ESP Valencia - Paterna Additional Locations Work Shift

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