As a Quality Engineer, you'll play a vital role in ensuring our products meet the highest standards of quality, safety, and efficacy. You'll work closely with cross-functional teams to develop and implement quality systems, processes, and procedures that drive continuous improvement and compliance with regulatory requirements.
Key Responsibilities:
Develop and implement quality systems, processes, and procedures that drive excellence and compliance.
Collaborate with teams to identify and mitigate quality risks, and implement corrective actions.
Analyze quality data, identify trends, and drive improvements that impact the bottom line.
Provide training and guidance to manufacturing and QA personnel to ensure a culture of quality.
Represent the company during external audits and regulatory inspections.
Requirements:
BS degree in a technical or engineering discipline.
3+ years of experience in a manufacturing environment, with experience in quality, process engineering, or a related field.
Strong knowledge of ISO 13485 and FDA/QSR regulations.
Excellent communication and problem-solving skills.
Ability to work independently with minimal direction.
Preferred Requirements:
CQE certification.
Experience with Six Sigma and Lean manufacturing.
Medical device industry experience.
Technical Skills:
Statistical software systems: Minitab, SPSS.
Measurement system analysis.
Sampling plans.
Familiarity with SAP or other ERP systems.
Microsoft Office: Excel, Word, PowerPoint.
What We Offer:
Opportunity to work on cutting-edge projects that transform lives.
Collaborative and dynamic work environment with a team of innovators.
Professional development and growth opportunities to help you achieve your goals.
Competitive salary and benefits package.
Recognition and rewards for outstanding performance.
Who We Are:
KARL STORZ is an independent, family-owned company headquartered in Germany's renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike.
With more than 9,000 associates worldwide and 2,600 in the US, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support to help healthcare facilities succeed. With onsite locations and field opportunities across the country, we attract a diverse and talented staff. It's not just about the tools we create-it's about the lives we change, together.
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