Description
GATT Technologies is recruiting for a Senior Quality Specialist, located in Nijmegen.
Join our dynamic team as a Senior Quality Specialist and play a pivotal role in ensuring the reliability and excellence of ETHIZIA, our innovative hemostatic sealing patch. Your expertise will directly impact patient outcomes, making a difference in surgical procedures worldwide while advancing the field of medical technology.
Key responsibilities:
Under the management of the Quality and Regulatory Compliance Lead, the Sr. Quality Specialist acts as the Change Control / Document Control and Nonconformance / CAPA process owner for the GATT site.
This position drives the continuous education, implementation and improvement of Quality Systems and compliance with QS regulation and ISO within the GATT facility and ensures that the site's Document & Change Control / Nonconformance / CAPA Processes and structure meet all business and regulatory requirements.
Furthermore, this position acts as the backup of the Quality and Regulatory Compliance Lead and provides guidance and assistance to ensure compliance of process procedures with applicable regulations and standards, such as, good laboratory practices, good clinical practices, quality system regulations, and organization of international standards including administrative support to the Quality organization.
Key responsibilities include:
- Act as the Nonconformance and CAPA process owner and represent the site on the worldwide NC and CAPA teams.
- Act as the Change and Document Control process owner and ensure adherence of the process at the site as well as act as SME for this process during regulatory inspections
- Conduct internal audits to verify compliance with quality management system standards and support external audits, including generating reports with corrective action plans.
- Identify root causes of quality issues and develops corrective actions and recommendations.
- Lead and participate in quality system improvement initiatives.
- Connect with Management and assist in the development of Quality Metrics to achieve company's Quality goals.
Qualifications
Education:
- University / bachelor’s Degree or Equivalent
Experience and skills:
Required:
- Minimum of 4-6 years work experience. Minimum of 3 years in similar environment with medical device or pharmaceutical.
- Able to communicate and writing skills in English (Dutch is a plus).
- Flexibility, integrity, independency and serve minded.
- Strong communication, human relation, problem solving and analytical skills.
- Ability to work independently and in teams.
- Ability to accurately perform detail-oriented work.
- Ability to maintain accuracy, consistency and quality of documentation and projects.
Preferred:
- Thorough understanding of medically regulated plant operations including knowledge of industry standards & regulations, processes and practices in a variety of different departments and operations.
- Experience with audits (Notified bodies and/or Competent Authorities).
- Ability to function in a controlled manner regulated by FDA cGMPs & ISO standards, and handle confidential data.
- Ability to develop and/or enhance quality system processes while ensuring compliance to applicable regulatory standards.
Other:
- Language required: English – Dutch is considered a plus.
- Six Sigma, LEAN and Auditor Certifications are preferred.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.