Quality Engineer II

Join a leader in medical technology innovation!

KARL STORZ is seeking a Quality Engineer II to drive product and process excellence in a fast-paced, regulated manufacturing environment.

Location: Charlton, MA

What's in it for me?

• You'll be directly contributing to patient safety and product performance in the medical device industry.
• Your work ensures compliance with critical FDA and ISO regulations, making a real-world impact.

• You'll build expertise in process validation, audits, CAPA, and quality systems, all high-value areas in regulated industries.

• You'll work across departments-R&D, manufacturing, QA, regulatory affairs-which builds both technical influence and leadership skills.
• Your role supports continuous improvement, giving you a visible impact on product and process outcomes.

• Competitive pay and benefits:

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!
• 3 weeks vacation, 11 holidays plus paid sick time
• Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
• 401(k)retirement savings plan providing a match of 60% of the employee's first 6% contribution (up to IRS limits)
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
• Fitness reimbursement of up to $200 annually
• And much more!

What you'll be doing:

• Support process validation, lead defect analysis, and corrective actions
• Support and assist with internal audits and regulatory inspections
• Analyze quality data to identify trends and drive continuous improvement
• Support CAPA, NCMR, and engineering change activities
• Collaborate with manufacturing, QA, and cross-functional teams
• Train personnel on quality processes and compliance

What you need to be considered:

• BS in Engineering or Technical field
• 3+ years within a manufacturing environment, with experience in quality, or process engineering preferred.
• Medical device experience highly preferred.
• CQE certification a plus.
• Proficiency in Microsoft Office, Minitab; Six Sigma/Lean a plus
• Strong analytical, communication, and problem-solving skills

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.

Why Join KARL STORZ?
Join a mission-driven leader in medical technology with a legacy of innovation and quality. You'll be part of a collaborative team that values expertise, initiative, and impact-where your work shapes the future of surgical care.

Apply today and take your career to the next level!

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