Senior Quality Assurance Engineer: Medical Devices

2 tygodni temu

Kraków, Lesser Poland Human4Human Recruitment Pełny etat

Senior Quality Assurance Engineer: Medical Devices

This role is designed for an experienced Senior Quality Assurance Engineer looking to take their career to the next level. We are seeking a highly skilled professional to lead our quality assurance team in the medical device industry.

  • Main 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.

Required Skills and Qualifications:

  • Experience in medical component 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.

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