Staff Quality Engineer

3 tygodni temu

Skawina, Lesser Poland Stryker Pełny etat

Are you passionate about ensuring product excellence and driving continuous improvement? We're seeking a proactive Staff Quality Engineer to join our dynamic team. In this role, you'll play a vital part in maintaining product quality, implementing process improvements, and fostering a culture of excellence.

What You'll Do:

Collaborate closely with various business functions to assess and enhance product and process quality. Provide guidance and oversight on Non-Conformance (NC) and Corrective and Preventive Action (CAPA) processes, leveraging your expertise in problem-solving and root cause analysis. Mentor and coach the quality team and other business functions on quality-related topics and activities, serving as a subject matter expert. Lead and manage quality initiatives and projects at both local and global levels. Serve as a recognized process owner in areas of expertise, including problem-solving, risk management, lean practices, and more. Contribute expert input into local, global, and corporate processes, driving continuous improvement and efficiency. Interpret KPI trends, taking proactive action to drive improvement. Advocate for Human Factor practices and lead efforts in identification and mitigation. Participate in internal and external audits, providing insightful narratives and descriptions of expertise areas. Support manufacturing transfers to other facilities, leading quality activities throughout the process. Take on management responsibilities in the absence of senior staff, ensuring continuity and excellence in operations.

Your qualifications:

Previous experience in a regulated environment is essential. Proficiency in understanding Med Device manufacturing processes, ISO 13485, and GMP standards. Lean/Six Sigma training is required, demonstrating your commitment to process improvement. Strong communication skills and keen attention to detail are crucial. Solid understanding of engineering and quality practices and methods. Willingness to work collaboratively within a multi-site team, with occasional travel. High-level knowledge and experience of Risk-Based and statistical techniques, including process risk assessment and statistical sampling. Excellent proficiency in both English and Polish, both oral and written. Ability to champion Quality initiatives cross-functionally, leading discussions to ensure optimal outcomes. Minimum of 6 years of experience in a Quality Department role.

Join Us Today:

If you're ready to make a meaningful impact in a challenging yet rewarding environment, apply now to become an integral part of our Quality team

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