Quality Engineer I

Cirtec Services GmbH; Rock Hill (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

Cirtec Medical Corporation is seeking a Quality Engineer to monitor and audit quality across manufactured goods for medical devices. You will analyze root causes, drive CAPAs, and partner with Engineering and Operations to ensure product quality and successful transfers to production.

The role requires a STEM degree, 0–2+ years of QA in manufacturing, and strong knowledge of GD&T, FMEA, DOE, and ISO 13485. Join a team focused on continuous improvement and regulatory compliance.

Qualifications

• Must have knowledge of GD&T, FMEA, DOE, and GR&R.
• Ability to read and interpret engineering drawings, schematics, and specifications.
• Familiarity with ISO 13485 quality systems.
• Excellent verbal and written communication skills.

Responsibilities

• Conduct root cause analysis and implement corrective actions for process/product concerns.
• Pursue continual improvements to enhance the quality system with cross-functional teams.
• Coordinate transfer to Production of new products in accordance with approved data.
• Support NPI activities with Engineering, Sales, and Customers.
• Prepare submission packages and maintain validation artifacts (FAI, PFMEA, Process Controls).
• Investigate non-conformances and recommend corrective actions to prevent recurrence.
• Assist quality inspectors to ensure compliance with QMS requirements.
• Conduct audits, close findings, and drive CAPAs under medical device quality standards (ISO 13485, CFR 820).
• Analyze failures and implement CAPAs to address customer complaints.
• Create and maintain quality documentation and reports.

Skills

GD&T

FMEA

DOE

GR&R

Engineering drawings

ISO 13485

Statistical Process Control

MS Office

Education

Bachelor's Degree in Engineering

Tools

MiniTab

Job description

Description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

The Quality Engineer primarily responsible for monitoring and auditing the quality of all manufactured goods in our medical device industry. This role will have a specific area/customer of responsibility and assist with various tasks and responsibilities assigned by the Quality Manager. The Quality Engineer will support the Quality department by analyzing and pin-pointing root causes and corrective actions (CAPAs).

Key Responsibilities:

• Conduct root cause analysis and implementation of corrective action for process/product related concerns.


• Responsible for continual improvement activities to enhance the quality system using cross-functional teams.


• Interfaces with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data.


• Interacts with Customers, Sales and Engineering on new product introduction (NPI) activities for new programs.


• Works with Engineering to coordinate and prepare sample submission packages; updates and maintains FAI, FMEAs, Process Flow diagrams and Process Control Plans.


• Works with Engineering and Operations to solve in-house quality concerns, reviews of nonconforming product, recommends disposition.


• Conducts investigations on non-conformance and recommends corrective action to prevent reoccurrence.


• Supports the Quality Inspectors to ensure that products and processes comply with relevant requirements of the quality management system.


• Conducts audits, including closing out audit findings, creating audit findings reports and determine proper corrective and preventive actions within regulated medical device-based quality systems (e.g., ISO 13485, CFR Part 820).


• Analyzes failures and implements corrective and preventive action to respond to customer complaints.


• Creates and maintains company quality documentation, such as quality procedures, work instructions, etc.


• Preparation of various quality reports.

Must Have:

• Bachelor's Degree in a technical/engineering field (STEM).


• 0-2+ years of experience in Quality Assurance in a manufacturing environment (rubber components and/or medical manufacturing highly preferred).


• Knowledge of GD&T, FMEA, DOE, GR&R activities.


• Must be able to read and interpret engineering drawings, schematics, and specifications.


• Familiarity of ISO 13485 quality systems.


• Excellent verbal and written skills to communicate at all levels within the organization as well as with customers and suppliers.


• Ability to provide concise direction in spoken or written formats.


• Possess a strong working knowledge of Statistical Process Control methods using intermediate and advanced statistics.


• Intermediate MS Office; must be able to create a variety of charts and reports to support quality activities.

Good to have:

• Basic MiniTab desired.


• CQE or CQA preferred.


• Six Sigma Green Belt certification preferred.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.