Quality Systems Specialist

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 https://www.jnj.comJob FunctionQualityJob Sub FunctionQuality SystemsJob CategoryProfessionalAll Job Posting Locations:Nijmegen, NetherlandsJob DescriptionAt 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 https://www.jnj.comGATT 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.Key ResponsibilitiesUnder 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 IncludeActs 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 CAPAAssist 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 inspectionsMaintains and implements communications to increase awareness and promote improvement of quality issues across the businessSupports external audits, including generating reports with corrective action plans and ensuring implementation of corrective actions in a timely mannerIdentifies root causes of quality issues and develops corrective actions and recommendations.Participates in quality system improvement initiatives.QualificationsEducation:University / bachelor’s Degree or EquivalentRequiredExperience and Skills: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.PreferredThorough 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.OtherLanguage required: English – Dutch is considered a plus.Six Sigma, LEAN and Auditor Certifications are preferredThe 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, the role includes an annual bonus of 10% based on performance.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 SkillsPreferred 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