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Senior NPI Quality Engineer
2 months ago
We are seeking a highly skilled Senior NPI Quality Engineer to join our Partner's team in the medical industry. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality standards in new product introductions.
Key Responsibilities- Foster Collaborative Relationships: Develop and maintain strong relationships with cross-functional teams, including Design Divisions, Advanced Operations, and GQO functions, to ensure seamless design transfer activities.
- Effective Communication: Communicate complex ideas and project requirements to internal customers, stakeholders, and project teams to ensure successful project transfers with high-quality outcomes.
- Risk Management: Apply risk management practices, particularly PFMEA, to ensure all Risk Management outputs comply with ISO14971 and identify appropriate production and process controls.
- Lean Inspection Strategies: Develop and implement lean inspection strategies and continuous improvement initiatives to enhance inspection methods, focusing on human error risk elimination.
- Validation and Verification: Support the development, execution, and approval of validation protocols and reports, influencing processes towards validation versus manual verification.
- Statistical Techniques: 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.
- Supplier Qualification: Support supplier qualification, validation, and certification processes, ensuring proper selection and establishment of Quality Agreements with suppliers.
- Design Transfer Agreement Plan: Represent quality assurance during the Design Transfer Agreement Plan (DTAP) process, ensuring robust NPI quality deliverables and efficient knowledge transfer post-launch.
- Experience: 4+ years of experience in a regulated manufacturing environment, particularly in new product/process introduction.
- Certification: Certification in Quality Engineering (CQE) or equivalent experience is desirable; Lean Six Sigma training is a distinct advantage.
- Knowledge: Strong familiarity with advanced product quality planning frameworks, ISO 13485, QSR, GDP, and GMP standards.
- Skills: Excellent analytical and problem-solving skills, with experience in using Lean Six Sigma tools like DMAIC for process improvement.
- Interpersonal Skills: Strong interpersonal skills with the ability to collaborate effectively with multidisciplinary teams and communicate complex ideas clearly in English, both oral and written.
- Competitive Salary: Your salary will be highly correlated with your skills and mindset.
- Comprehensive Benefits: A comprehensive benefits package that includes health insurance, and other perks designed to support your overall well-being and financial security.
- Opportunities for Growth: An access to training programs, and resources to help you grow and advance in your career.
- Cultural Diversity: An opportunity to broaden your horizons and gain valuable experience in diverse cultural settings.
- Flexible Work Arrangements: Flexible work arrangements and initiatives to support employee well-being, ensuring you can thrive both professionally and personally.
