.
Senior NPI Quality Engineer
  • Kraków
Senior NPI Quality Engineer
Kraków, Kraków, Polska
Human4Human Recruitment
22. 10. 2024
Informacje o stanowisku

Are you an experienced Senior NPI Quality Engineer looking for a new challenge? Look no further! Join our Partner’s team, a leader in innovation and excellence in the medical industry. If youre passionate about quality assurance, new product introductions, and working in a collaborative environment, we want to hear from you. If youre ready to contribute to the development of cutting-edge products and technologies in a dynamic work setting, apply now for the Sr. NPI Quality Engineer position. Join us in shaping the future of the medical industry! 

 

 

 

Senior NPI Quality Engineer 

Your responsibilities:
  • Foster collaborative relationships across Design Divisions, Advanced Operations, and GQO functions for design transfer activities,
  • Communicate effectively with internal customers, stakeholders, and project teams to ensure successful project transfers with high-quality outcomes,
  • Proficient in risk management practices, particularly PFMEA, ensuring all Risk Management outputs comply with ISO14971 and identifying appropriate production and process controls,
  • Develop and implement lean inspection strategies and continuous improvement initiatives to enhance inspection methods, focusing on human error risk elimination,
  • Support the development, execution, and approval of validation protocols and reports, influencing processes towards validation versus manual verification,
  • Apply statistical techniques to develop robust, predictive quality systems and provide expertise for non-conformities (NCs) and corrective/preventive actions (CAPAs) related to new products,
  • Support supplier qualification, validation, and certification processes, ensuring proper selection and establishment of Quality Agreements with suppliers,
  • Represent quality assurance during the Design Transfer Agreement Plan (DTAP) process, ensuring robust NPI quality deliverables and efficient knowledge transfer post-launch.
We require:
  • Experience in medical component is a strong asset,
  • Bachelors degree in Engineering or related field with 4+ years of experience in a regulated manufacturing environment, particularly in new product/process introduction,
  • Certification in Quality Engineering (CQE) or equivalent experience is desirable; Lean Six Sigma training is a distinct advantage,
  • Strong familiarity with advanced product quality planning frameworks, ISO 13485, QSR, GDP, and GMP standards,
  • Proficient understanding of medical device manufacturing processes and competency in metrology, including interpreting complex engineering drawings and geometrical dimensioning and tolerance,
  • Excellent analytical and problem-solving skills, with experience in using Lean Six Sigma tools like DMAIC for process improvement,
  • Ability to manage multiple projects simultaneously, plan, organize, and implement concurrent tasks efficiently,
  • Strong interpersonal skills with the ability to collaborate effectively with multidisciplinary teams and communicate complex ideas clearly in English, both oral and written,
  • Basic knowledge of risk-based and statistical techniques, including process risk, FMEA, statistical sampling plans, and process capability, with a continuous improvement mindset.
We can offer:
  • Your salary will be highly correlated with your skills and mindset: from 18.000 up to 22.000+ gross PLN,
  • A comprehensive benefits package that includes health insurance, and other perks designed to support your overall well-being and financial security,
  • An opportunity to work with cutting-edge automotive technologies and contribute to shaping the future of medical industry,
  • An access to training programs, and resources to help you grow and advance in your career,
  • An opportunity to broaden your horizons and gain valuable experience in diverse cultural settings,
  • A flexible work arrangements and initiatives to support employee well-being, ensuring you can thrive both professionally and personally.

 

 

Recruitment process steps:

 

  • Send your CV via H4H form or email: biuro@h4h.com.pl
  • A phone call with H4H IT Consultant to enrich your application with missing details.
  • A video call with our Partner’s Tech Leader, to evaluate your skills. We may redo it whether we have some better job offers for you.
  • A video call with end Client representatives - automotive component manufacturing company to ensure good understanding of the role for your side and enable you to ask any questions regarding your new ro

  • Praca Kraków
  • Kraków - Oferty pracy w okolicznych lokalizacjach


96 756
15 987