Quality Systems Specialist

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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Job Description:

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

Join our dynamic team as a Quality Systems 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 Quality Systems Specialist acts as the Change Control / Document Control and/or 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.

• Participate in quality system improvement initiatives.

Qualifications

Education:

• University / bachelor’s Degree or Equivalent

Experience and Skills:

Required:

• Minimum of 2-5 years work experience. Minimum of 1 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.

The anticipated base pay range for this position is 53,500 EUR to 85,445 EUR on an annual basis and includes 8% holiday allowance.

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, and 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.

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