Quality Systems Specialist

GATT Technologies is recruiting for a Quality Specialist, located in Nijmegen.

Join our dynamic team as a 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.

Under the management of the Quality Systems Lead, the 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 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:

• Acts as the Nonconformance and/or CAPA process owner and represent the site on the worldwide teams.
• Provides education/training as needed regarding Document and Change Control, NC and CAPA
• Assist in the development of Quality Metrics to achieve company's Quality goals. Reports NC and CAPA scorecard results, as needed.
• Acts 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
• Maintains and implements communications to increase awareness and promote improvement of quality issues across the business
• Supports external audits, including generating reports with corrective action plans and ensuring implementation of corrective actions in a timely manner
• Identifies root causes of quality issues and develops corrective actions and recommendations
• Participates in quality system improvement initiatives.

Qualifications

Required:

• Minimum of 2-5 years work experience. Minimum of 2 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

Preferred Skills:

Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaborating, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People

Location: Nijmegen, NL