Informacje o stanowisku
Are you an experienced Senior NPI Quality Engineer looking for a new challenge? Look no further! Join our Partner’s team, a leader in innovation and excellence in the medical industry. If youre passionate about quality assurance, new product introductions, and working in a collaborative environment, we want to hear from you. If youre ready to contribute to the development of cutting-edge products and technologies in a dynamic work setting, apply now for the Sr. NPI Quality Engineer position. Join us in shaping the future of the medical industry!
Senior NPI Quality Engineer
Your 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.
We require:
- Experience in medical component is a strong asset,
- Bachelors 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.
We can 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 automotive technologies and contribute to shaping the future of medical 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 steps:
- 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 ro
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