Senior Quality Systems Specialist

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Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Nijmegen, Netherlands

Job 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 Systems Lead, the Senior Quality Systems Specialist acts as supervisor to Nonconformance / CAPA process and support to the Change Control / Training management process  for the GATT site as well as supports External Audit management process.

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 QMS Processes and structure meet all business and regulatory requirements.

Furthermore, this position acts as the backup of the Quality Systems 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:

• Supervisor to Nonconformance / CAPA, Escalation process and support to the Change Control / Training management process at the site and ensures adherence of the process at the site as well as acts as SME for this process during regulatory inspections
• Uses complex statistical methods, quality tools and computer-generated reports to continuously improve process capability
• Provides education/training as needed regarding QMS process
• Acts as process owner for data analysis to the DRB and preparation to Management Review, as appropriate
• Quality Planning: Coordinates the control of Quality Planning processes
• 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.
• Represents the site in the worldwide process teams

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.

A pre-identified candidate for consideration has been identified. However, all applications will be considered

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.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

 

 

Required Skills:

 

 

Preferred Skills:

Agility Jumps, Analytical Reasoning, Analytics Dashboards, Coaching, Collaboration, 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, System Audits, Systems Analysis

  

 

The anticipated base pay range for this position is:

€64 000,00 - €103 040,00

 

 

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

 

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.