Quality Engineer II

Location: Charlton, MA | Job Type: Full-Time | Industry: Medical Device Manufacturing

Drive quality. Advance innovation. Make an impact.

Join KARL STORZ as a Quality Engineer II, where you'll play a key role in ensuring product and process excellence in a regulated, fast-paced medical device environment. This role supports new product development, continuous improvement, and compliance activities across the quality system.

• Lead and support process validations, root cause investigations, CAPA activities, and continuous improvement initiatives

• Conduct internal audits and prepare for external/regulatory audits (FDA, ISO 13485)

• Develop and implement test and measurement methods

• Support nonconformance, documentation, training, and quality data analysis

• Partner cross-functionally with QA, Engineering, and Manufacturing teams

• BS in Engineering or related technical field

• 2+ years in a manufacturing environment (medical device preferred)

• Familiarity with ISO 13485, FDA/QSR, and quality system regulations

• Strong analytical, organizational, and communication skills (ability to communicate with personnel at all levels, both verbally and in writing)

• Knowledge of Six Sigma, Lean, and Minitab a plus

• CQE certification preferred

• A self starter able to function independently with minimum direction

• Make a Meaningful Impact
  You'll play a vital role in ensuring product safety, performance, and regulatory compliance - ultimately helping improve patient outcomes around the world.

• Join a Company That Invests in You
  We offer career development, technical training, and the opportunity to grow within a global, mission-driven organization.

• Work with Purpose and Precision
  Be part of a collaborative environment that values high standards, innovation, and continuous improvement - not just checking boxes.

• Tackle Complex, Rewarding Challenges
  From leading process validations to supporting audits and launching new products, you'll work on real problems that matter.

• Be Trusted with Ownership
  Lead validation, support audits, and influence process improvements - your voice matters here.

• Stay Engaged with Varied Work
  This role includes occasional travel (up to 10%) and frequent local driving to support quality activities across sites. No two weeks look the same.

• Enjoy Competitive Rewards
  Receive a strong compensation package, including health and wellness benefits, 401(k) with match, paid time off, and more.

• Be part of a mission-driven, collaborative environment

• Gain exposure to complex products and global operations

• Grow your skills in quality leadership and regulatory compliance

• Competitive salary, benefits, and career development opportunities

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 9800+ 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.

Ready to raise the standard of quality? Apply now and join a team committed to improving patient outcomes through precision and excellence.

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