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Senior Quality Project Engineer

Coordinate validation activities for high-quality injectable medical devices
Szczecin, West Pomeranian Voivodeship, Poland
Senior
10 hours agoBe an early applicant
Nemera

Nemera

A global leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, and generics industries.

Senior Quality Project Engineer

Nemera Szczecin Sp. z o.o. is a member of the global Nemera group, a leader in the production of drug delivery devices. Our branches are located in France, the United States, Germany, and Brazil. In Szczecin, we are specialists in the production of high-quality injectable devices for drug administration, such as insulin or growth hormone. Our team is a group of highly qualified specialists who passionately create innovative solutions, improving the quality of life for patients worldwide.

Position Description

  • Supervising and coordinating projects related to quality engineering, with particular attention to the medical industry.
  • Developing, implementing, and overseeing validation processes (IQ, OQ, PQ) and validation tests for new and existing products/processes.
  • Analyzing and solving complex quality issues, identifying root causes, and implementing corrective and preventive actions.
  • Active collaboration with R&D, Production, and Regulatory departments to ensure product compliance with quality standards and legal requirements.
  • Creating, updating, and managing quality documentation, including specifications, procedures, and validation reports.
  • Participating in internal and external audits, representing the project quality area.

Qualifications

  • Higher technical education (preferred fields: quality engineering, mechanics, automation) and a minimum of 3 years of experience in a similar position, preferably in the medical industry.
  • Proven knowledge and practical experience in process validation (IQ, OQ, PQ) and validation tests in a regulated environment.
  • Proficiency in interpreting technical documentation, technical drawings, and familiarity with measurement tools.
  • Practical knowledge of quality tools (FMEA, SPC) and deep understanding of quality control principles and error assessment.
  • Communicative knowledge of English in speech and writing, enabling free international cooperation.
  • Specialized knowledge of plastics and manufacturing technology, especially in the context of medical products.

Additional Information

What We Offer:

  • Stable employment in a dynamically developing medical sector company focused on innovation.
  • Real opportunity to influence the strategic quality and development of advanced technology products.
  • Attractive non-monetary benefits package, including private medical care, sports card, and life insurance.
  • Access to a dedicated training budget for developing skills and industry certifications.
  • Modern work environment equipped with advanced tools and technologies.
  • Organizational culture promoting cooperation, knowledge exchange, and support in achieving ambitious goals.

In Nemera, we value diversity and inclusivity. We are proud to be an equal opportunity employer and encourage applications from people of different backgrounds, genders, sexual orientations, and age groups.

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Senior Quality Project Engineer
Szczecin, West Pomeranian Voivodeship, Poland
Engineering
About Nemera
A global leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, and generics industries.