KARL STORZ Endoscopy - America
Sterilization/Cleanroom Quality Engineer IV
KARL STORZ Endoscopy - America, Bellingham, Massachusetts, us, 02019
The
Quality Engineer IV
is a senior-level professional responsible for supporting the quality assurance of both sterile and non-sterile products, focusing on KARL STORZ’s Advanced Machining Center (AMC) and Single Sterile Use (SSU) production. The role ensures compliance with quality and sterilization standards, focusing on patient safety and regulatory requirements.
What's in it for me?
Leadership Opportunities:
You’ll take a lead role in quality initiatives, process improvements, and compliance, with the chance to mentor and supervise technicians.
Professional Growth:
You’ll work with advanced technologies like sterilization processes and cleanroom environments, gaining specialized expertise in medical device manufacturing and regulatory standards (FDA, ISO, MDR).
Cross-functional Collaboration:
You’ll engage with various teams (engineering, production, regulatory) to drive high-impact projects and continuous improvement.
Job Security and Impact:
You’ll play a crucial role in ensuring patient safety and product quality, contributing directly to healthcare innovation.
Advanced Tools and Systems:
Access to cutting-edge tools, quality systems, and software (SAP, Six Sigma, SPC) enhances your technical skill set.
Challenging and Diverse Work:
Exposure to a variety of processes, including process validation, defect analysis, audits, and environmental monitoring, ensures dynamic day-to-day responsibilities.
What you’ll be doing:
Provide sterilization expertise and oversee sterilization release processes.
Support continuous improvement in product and process quality, including validation, defect analysis, CAPA, and internal audits.
Ensure compliance with FDA, ISO, and MDR regulations, supporting both internal and external audits.
Lead initiatives to improve quality systems, lean manufacturing, and Six Sigma activities.
Analyze quality data, prepare inspection procedures, and review engineering changes.
Supervise and mentor technicians and provide training to QA and manufacturing teams.
Ensure environmental monitoring and product sterility requirements are met.
What you need to be considered:
Bachelor’s degree in engineering and 5+ years of experience in medical device manufacturing and quality assurance.
Knowledge of sterilization, clean rooms, machining, and injection molding.
Proficiency in statistics, SPC, and quality engineering tools.
Strong communication, problem-solving, and organizational skills.
Experience with MS Office, SAP, and quality tools like Six Sigma and Minitab preferred.
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 9000+ employees worldwide, 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 positive patient outcomes.
It 's not just about the tools we create—it’s about the lives we change, together.
#LI-BL1
Quality Engineer IV
is a senior-level professional responsible for supporting the quality assurance of both sterile and non-sterile products, focusing on KARL STORZ’s Advanced Machining Center (AMC) and Single Sterile Use (SSU) production. The role ensures compliance with quality and sterilization standards, focusing on patient safety and regulatory requirements.
What's in it for me?
Leadership Opportunities:
You’ll take a lead role in quality initiatives, process improvements, and compliance, with the chance to mentor and supervise technicians.
Professional Growth:
You’ll work with advanced technologies like sterilization processes and cleanroom environments, gaining specialized expertise in medical device manufacturing and regulatory standards (FDA, ISO, MDR).
Cross-functional Collaboration:
You’ll engage with various teams (engineering, production, regulatory) to drive high-impact projects and continuous improvement.
Job Security and Impact:
You’ll play a crucial role in ensuring patient safety and product quality, contributing directly to healthcare innovation.
Advanced Tools and Systems:
Access to cutting-edge tools, quality systems, and software (SAP, Six Sigma, SPC) enhances your technical skill set.
Challenging and Diverse Work:
Exposure to a variety of processes, including process validation, defect analysis, audits, and environmental monitoring, ensures dynamic day-to-day responsibilities.
What you’ll be doing:
Provide sterilization expertise and oversee sterilization release processes.
Support continuous improvement in product and process quality, including validation, defect analysis, CAPA, and internal audits.
Ensure compliance with FDA, ISO, and MDR regulations, supporting both internal and external audits.
Lead initiatives to improve quality systems, lean manufacturing, and Six Sigma activities.
Analyze quality data, prepare inspection procedures, and review engineering changes.
Supervise and mentor technicians and provide training to QA and manufacturing teams.
Ensure environmental monitoring and product sterility requirements are met.
What you need to be considered:
Bachelor’s degree in engineering and 5+ years of experience in medical device manufacturing and quality assurance.
Knowledge of sterilization, clean rooms, machining, and injection molding.
Proficiency in statistics, SPC, and quality engineering tools.
Strong communication, problem-solving, and organizational skills.
Experience with MS Office, SAP, and quality tools like Six Sigma and Minitab preferred.
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 9000+ employees worldwide, 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 positive patient outcomes.
It 's not just about the tools we create—it’s about the lives we change, together.
#LI-BL1