Nijmegen, NLD
24 hours ago
Senior QC Engineer
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.com **Job Function:** Quality **Job Sub** **Function:** Quality Control **Job Category:** Business Enablement/Support **All Job Posting Locations:** Nijmegen, Netherlands **Job Description:** We are happy to invite candidates for the position of **Senior QC Engineer** with a **1 year fixed-term contract** at GATT Technologies, a dynamic company founded in 2011 and located in Nijmegen, The Netherlands. The role is opened for one year fixed term contract. In this role, the Senior QC Engineer will be pivotal in ensuring and improving the execution of QC activities, ensuring our innovative products consistently meet the highest industry standards. As GATT continues to lead in the development of next-generation surgical solutions, your expertise will help craft our commitment to making a tangible impact in the medical device sector. **You will be responsible for:** + Lead and handle QC projects aimed at improving laboratory processes and methodologies, ensuring consistency to quality standards. + Supervise and conduct Non-Conformance (NC) investigations and lead Corrective and Preventive Actions (CAPA) to identify root causes and implement effective solutions to prevent recurrence. + Prepare for and participate in internal and external audits by ensuring that documentation is complete and follows all applicable ISO and regulatory standards. + Work together with the QC Release team to ensure consistent quality practices and to drive improvements across both teams. + Team up with colleagues from other departments or sites to set up + Develop and maintain quality specifications and user requirement specifications for QC materials, chemicals, and equipment, ensuring compliance with industry standards. + Supervise the validation, qualification, and implementation of new analytical methods and ensure that all laboratory procedures follow relevant regulations. + Lead training initiatives for QC staff to maintain high standards of technical proficiency and ensure familiarity with QC procedures and regulatory requirements. + Conduct risk assessments related to quality control activities and implement appropriate risk mitigation strategies to ensure product safety and efficacy. + Ensure compliance with Health, Safety, and Environmental practices in the laboratory and develop a culture of quality and safety within the QC team. + Perform additional duties as assigned to support the overall objectives of the Laboratory Operational Excellence team. **Qualifications/Requirements:** + Preferably holds a Bachelor's/Master’s degree or equivalent experience from a university or technical college in a relevant scientific field or engineering (e.g., Biology, Microbiology, Chemistry, Biochemistry, Material Sciences, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Bioengineering, Pharmacy, Physics, or Biophysics). + Leadership mentality, willing to support and help grow operators' competencies. + Strong social skills to develop and articulate ideas optimally. + Ability to analyze and solve problems using logic and difficulty, demonstrating continuous learning. + Professional integrity and a strong ethical character. + Proficient in written and spoken English. + Proficient in Word, Excel, PowerPoint, and Outlook. + Familiarity with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and knowledge of Non-Conformities (NC) and Corrective and Preventive Actions (CAPA) is helpful.
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