Quality Engineer I — Medical Devices & Validation

Cirtec Medical Corp.; Sturtevant (WI); On-site; USD 78,000 - 94,000; Full time

Job summary

Cirtec Medical Corp. is seeking a Quality Engineer to monitor and audit the quality of all manufactured goods in a medical device environment.

The role focuses on defect root cause analysis and CAPA support while interfacing with customers and suppliers on engineering projects. You will lead validation activities, develop SOPs, quality plans, and CAPA processes, with emphasis on continuous improvement and adherence to ISO 13485 and 21 CFR 820.

Qualifications

• 1+ years of relevant work experience.
• Fluent in English (read/write/speak).
• Must implement quality programs, interpret data, and present to management.
• ISO 13485 background.
• Medical Device 21 CFR 820 knowledge.
• Extrusion/Molding and/or manufacturing experience.
• Strong verbal communication and organizational skills.

Responsibilities

• Provide Quality Engineering support for engineering project development, or sustained manufacturing.
• Provide Quality Project Management support for product transfers from development to validation.
• Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.
• Develop and maintain Validation Standard Operating Procedures.
• Develop and maintain project Quality Plan for assigned projects.
• Develop protocols, perform statistical analyses, and write reports for validations and formal process development (DOE involvement).
• Support IQ and OQ protocols to ensure compliance with the Quality System.
• Provide Quality Engineering support for manufacturing.
• CAPA system owner responsible for support of corrective action procedures.
• Interact with customers and suppliers to resolve CAPA and complaint investigations and in support of manufacturing.
• Provide Quality Support for disposition of material via NCRs.
• Provide Quality Project Management Support for product transfers from validation to production.
• Vendor approval and assess vendor performance data (SCAR/on time).
• Review and document procedure changes for quality requirements and compliance with the quality system.
• Develop quality systems and procedures as needed.
• Audit support for third party audits, customer audits and internal audits.
• Support continuous improvement initiatives for production processes.
• Develop and maintain production quality control plans.
• Initiate and maintain SPC for production processes.
• Support FMECA and DOE as applicable.
• Back up to Quality Systems Administrator.
• Complies with company, quality and safety standards, policies, and procedures.

Skills

Quality Engineering

Data analysis

Verbal communication

Organizational skills

Project management

MS Office

ISO 13485

21 CFR 820 knowledge

Extrusion/manufacturing experience

Tools

MS Office Suite

Job description

Cirtec Medical Corp. is seeking a Quality Engineer to monitor and audit the quality of all manufactured goods in a medical device environment.

The role focuses on defect root cause analysis and CAPA support while interfacing with customers and suppliers on engineering projects. You will lead validation activities, develop SOPs, quality plans, and CAPA processes, with emphasis on continuous improvement and adherence to ISO 13485 and 21 CFR 820.