Kraków 18.000 - 22.000 PLN
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 you're passionate about quality assurance, new product introductions, and working in a collaborative environment, we want to hear from you. If you're 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:
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Foster collaborative relationships across Design Divisions, Advanced Operations, and GQO functions for design transfer activities,
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Communicate effectively with internal customers, stakeholders, and project teams to ensure successful project transfers with high-quality outcomes,
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Proficient in risk management practices, particularly PFMEA, ensuring all Risk Management outputs comply with ISO14971 and identifying appropriate production and process controls,
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Develop and implement lean inspection strategies and continuous improvement initiatives to enhance inspection methods, focusing on human error risk elimination,
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Support the development, execution, and approval of validation protocols and reports, influencing processes towards validation versus manual verification,
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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,
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Support supplier qualification, validation, and certification processes, ensuring proper selection and establishment of Quality Agreements with suppliers,
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Represent quality assurance during the Design Transfer Agreement Plan (DTAP) process, ensuring robust NPI quality deliverables and efficient knowledge transfer post-launch.
We require:
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Experience in medical component is a strong asset,
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Bachelor's degree in Engineering or related field with 4+ years of experience in a regulated manufacturing environment, particularly in new product/process introduction,
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Certification in Quality Engineering (CQE) or equivalent experience is desirable; Lean Six Sigma training is a distinct advantage,
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Strong familiarity with advanced product quality planning frameworks, ISO 13485, QSR, GDP, and GMP standards,
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Proficient understanding of medical device manufacturing processes and competency in metrology, including interpreting complex engineering drawings and geometrical dimensioning and tolerance,
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Excellent analytical and problem-solving skills, with experience in using Lean Six Sigma tools like DMAIC for process improvement,
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Ability to manage multiple projects simultaneously, plan, organize, and implement concurrent tasks efficiently,
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Strong interpersonal skills with the ability to collaborate effectively with multidisciplinary teams and communicate complex ideas clearly in English, both oral and written,
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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:
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Your salary will be highly correlated with your skills and mindset: from 18.000 up to 22.000+ gross PLN,
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A comprehensive benefits package that includes health insurance, and other perks designed to support your overall well-being and financial security,
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An opportunity to work with cutting-edge automotive technologies and contribute to shaping the future of medical industry,
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An access to training programs, and resources to help you grow and advance in your career,
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An opportunity to broaden your horizons and gain valuable experience in diverse cultural settings,
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A flexible work arrangements and initiatives to support employee well-being, ensuring you can thrive both professionally and personally.
Recruitment process steps:
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Send your CV via H4H form or email: biuro@h4h.com.pl
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A phone call with H4H IT Consultant to enrich your application with missing details.
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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.
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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 role.
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A short video-call or phone call with our Partner’s HR Business Partner to check in depth the alignment between you and values and culture of the Company. Financial negotiations are welcomed :)
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Welcome aboard!
About our recruitment process:
Our recruitment process is tailored to do our best to avoid that you or we realize that we’re not a perfect fit in two or six months. It might seem long, but every step serves a purpose and will allow us to get to know you better as much as it’ll help you understand more where you’ll be stepping in.
We also want you to have time to ask all your questions regarding your job description, the long-term vision of your team and the company, our values, with the relevant interlocutor in front of you.
The steps mentioned above can be rearranged depending on yours and the interviewer’s availability.
How to nail your application:
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Tailor your CV & application to our specific job description and company. Attention to detail is important as an employee as it is as an applicant!
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Complete the different steps of the application process in a timely manner, to ensure you don’t miss out on this opportunity!
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Help us synchronize your availability with our Managers’ calendars to fulfil the video calls.
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Prepare your interviews and the questions you will ask at each step, depending on who’s conducting it.
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Any copy-pasted or non-personalized application will not be considered.
Direct contact to our TA Specialist:
Albert: tel.: +48 730 922 375, a.welk@h4h.com.pl
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