Quality Engineer II
Charlton, MA, US, 01507
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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KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member’s base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.
Nearest Major Market: Worcester