Senior NPI Quality Assurance Specialist

8 godzin temu

Kraków, Lesser Poland Human4Human Recruitment Pełny etat
Senior NPI Quality Engineer

We are seeking a highly skilled Senior NPI Quality Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality standards are met in the development and introduction of new products.

Key Responsibilities:
  • Foster strong relationships with cross-functional teams to ensure seamless design transfer activities.
  • Communicate effectively with internal stakeholders and project teams to ensure successful project transfers with high-quality outcomes.
  • Develop and implement lean inspection strategies and continuous improvement initiatives to enhance inspection methods and reduce human error risk.
  • 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 and corrective/preventive actions 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.
Requirements:
  • Experience in medical component manufacturing is a strong asset.
  • Bachelor's 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.
What We 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 medical technologies and contribute to shaping the future of the 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:
  • 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 role.
  • A short video-call or phone call with our Partner's HR Business Partner to check in depth the alignment between you and values and culture of the Company. Financial negotiations are welcomed :)
  • Welcome aboard

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