Senior Quality Engineer

2 weeks ago

Bellingham, United States KARL STORZ Endoscopy - America Full time

Join our team as a Quality Engineer II and drive continuous improvement in product and process quality within a medical device manufacturing environment.

 

Why This Role is a Great Opportunity for You:


Impactful Work: You’ll play a key role in improving the quality and safety of life-saving medical devices, directly impacting patient outcomes and healthcare advancements.
Career Growth: Gain exposure to critical quality systems like FDA/QSR and ISO 13485, positioning yourself for leadership roles in medical device or related industries.
Professional Development: You'll have the opportunity to develop valuable skills in Six Sigma, Lean manufacturing, process validation, and more, setting you up for success in high-demand fields.
Cross-Functional Collaboration: Work closely with teams across engineering, manufacturing, and regulatory affairs, broadening your network and experience.
Innovative Environment: Join a forward-thinking company that prioritizes continuous improvement, innovation, and employee development.
Competitive Benefits: Enjoy a comprehensive benefits package, opportunities for further education, and a work environment that promotes work-life balance.


What you’ll be doing:


You’ll support new product development, oversee audits, ensure compliance with FDA/QSR regulations, and facilitate corrective actions.
Manage quality systems, audits, and CAPA investigations.
Validate processes, analyze defects, and support nonconforming material disposition.
Prepare quality metrics, reports, and support external audits.
Provide training to manufacturing and QA personnel.


What you’ll need to be considered:


BS in Engineering; 3+ years in manufacturing (medical device experience preferred).
Strong knowledge of ISO 13485, FDA/QSR regulations.
Proficiency in Excel, Word, Minitab; Six Sigma/Lean Manufacturing is a plus.
Excellent communication and problem-solving skills.
Ability to travel up to 10%.


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 a footprint on every continent in the world, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver position patient outcomes.

 

It's not just about the tools we create—it’s about the lives we change, together. 

 

#LI-BL1

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