Senior NPI Quality Assurance Specialist

6 godzin temu

Kraków, Lesser Poland Human4Human Recruitment Pełny etat
About the Role:

As a Senior NPI Quality Assurance Specialist, you will play a crucial role in ensuring the quality and safety of our medical products. Your primary responsibility will be to oversee the design transfer process, collaborating closely with cross-functional teams to guarantee seamless product introductions. Your expertise in quality assurance will be instrumental in identifying and mitigating risks, while your analytical skills will help you develop and implement effective inspection strategies. With a strong focus on continuous improvement, you will drive process excellence and contribute to the development of cutting-edge medical technologies.

Key Responsibilities:
  • Collaborate with design divisions, advanced operations, and quality functions to ensure successful design transfer activities
  • Communicate effectively with internal customers, stakeholders, and project teams to ensure high-quality project outcomes
  • Develop and implement lean inspection strategies to enhance quality and reduce human error risk
  • Support the development and execution of validation protocols and reports, promoting a culture of validation over manual verification
  • Apply statistical techniques to develop robust quality systems and provide expertise on non-conformities and corrective actions
  • Support supplier qualification, validation, and certification processes to ensure quality agreements are in place
  • Represent quality assurance during the design transfer agreement plan process, ensuring robust quality deliverables and efficient knowledge transfer

Requirements:
  • 4+ years of experience in a regulated manufacturing environment, particularly in new product introduction
  • Bachelor's degree in Engineering or a related field
  • 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
  • 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
  • Basic knowledge of risk-based and statistical techniques, including process risk, FMEA, statistical sampling plans, and process capability

What We Offer:
  • Competitive salary correlated with your skills and mindset
  • A comprehensive benefits package, including 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
  • 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
  • Flexible work arrangements and initiatives to support employee well-being

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