About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com.

Position Summary

The Quality Systems Engineer will be responsible for providing core quality business process support & administration enabling enterprise level compliance. This position is responsible for ensuring a compliant Quality Management system including analysis, development, and revision of QMS processes, performing monitoring and continuous improvement, ensuring accuracy and compliance with relevant standards. This position will be tasked with direct facilitation and administration of core business processes to include Engineering/Document Change Orders, CAPA, Management Review, Standards Library, Internal Audit, New Customer Audit, Regulatory Audit, and QMS/Regulatory Training.

Responsibilities

• Identify, develop, and maintain relevant QMS programs to promote quality awareness and ensure compliance to company policies and procedures including:
  • Engineering & Document Changes
  • Corrective & Preventive Action
  • Standards Library Administration
  • Internal Audit Management
  • Customer Audit Management
  • Regulatory Audit management
  • Facilitating QMS & Regulatory Training Management
• Lead internal, external and supplier audits, including audit preparation, execution, reporting and follow-up activities
• Manage the internal audit program from the selection and training of the internal audit group through the implementation of effective corrective actions
• Assist in the definition of and continuous improvement of quality system business processes compliant to requirements outlined in ISO 9001, ISO 13485, and/or FDA QSR.
• Active participation in internal audits associated to ISO 9001, ISO 13485, and/or FDA QSR regulatory standards.
• Technical content writer of new and/or revising procedure/policy content within scope of the quality system.
• Analyze data and identify improvement opportunities.
• Support audit activities such as closing out audit findings, creating audit finding reports and collaborating on determining the proper corrective and preventative actions.
• Implement, monitor, lead and assist Corrective and Preventive Actions (CAPAs) that result from second, third-party, and internal audits.
• Technical contributor to initiatives associated to:
  • Business intelligence reporting and dashboard design & validation.
  • Enterprise business workflow design & administration
  • Quality system business process automation through software based systems.
• Ensure business systems are supported, maintained, and functioning to defined requirements.
• Support and comply with the company Quality System, ISO, and medical device requirements
• Read, understand, and follow work instructions and standard work
• Participate in required company meetings
• Maintain an organized work area (5S)
• Participate in the Operational Excellence Program
• Complete all other work duties as assigned
• Ability to work in a manufacturing environment

Qualifications

• Bachelor’s Degree in Computer Science, Software Engineering, Programming, or related STEM certified program.
• 5+ years of experience working with quality management systems in regulated environment (ISO 13485, EUMDR, FDA)
• Knowledge of quality systems, regulatory requirements, and industry standards
• Academic experience with business intelligence software tools
• Ability to consistently achieve short and long-term business results
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written communication skills
• Attention to detail
• Organizational skills
• Ability to work in a fast-paced team environment
• Ability to prioritize and multitask
• Ability to travel up to 15%

What is it like to work at Cretex Medical?

We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.

Here are some of things that employees have said about working for Cretex Medical:

• “The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.”
• “I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.”
• “I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.”

We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.

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