Senior NPI Quality Assurance Engineer

3 days ago

Banana Shire, Australia Human4Human Recruitment Full time
About the Role

We are seeking a highly skilled Senior NPI Quality Assurance Engineer to join our team at Human4Human Recruitment. As a key member of our organization, you will be responsible for ensuring the quality and integrity of our products throughout the design transfer process.

Key Responsibilities
  • Foster collaborative relationships with cross-functional teams, including Design Divisions, Advanced Operations, and GQO functions, to ensure seamless design transfer activities.
  • Communicate effectively with internal stakeholders, customers, 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
  • A highly competitive salary package, with a strong correlation between skills and compensation.
  • 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.
  • 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 arrangement and initiatives to support employee well-being, ensuring you can thrive both professionally and personally.

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