Senior Quality Engineer

2 weeks ago

Franklin, United States Disability Solutions 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

Eligible Employee 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

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures.

Credentialing requirements at KARL STORZ

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.

Pay Transparency

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.

Equal Employment Opportunity & Reasonable Accommodation Statement

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.

Get in Contact

Becky Ledford

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