Quality Engineer I

Cirtec-Medica; 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

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:

This position is primarily responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. Will work to not only find defects, but also to find the cause of the defect and develop a solution. Interact with customers and suppliers in support of engineering projects.

Key Responsibilities:

• Provide Quality Engineering support for engineering project development, or sustained manufacturing.
• Provide Quality Project Management support as needed 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, which requires quality-engineering involvement such as DOEs.
• Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
• Provide Quality Engineering support for manufacturing.
• CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures.
• Interact with customers and suppliers to resolve CAPA and complaint investigations and in support of manufacturing.
• Provide Quality Support for the disposition of material via NCR’s.
• Provide Quality Project Management Support as needed for product transfers from validation to production.
• Vendor approval and maintain and assess vendor performance data (i.e., 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 the implementation of continuous improvement initiatives for production processes.
• Develop and maintain production quality control plans.
• Initiate and maintain SPC (Statistical Process Control) for production processes.
• Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.
• Back up to Quality Systems Administrator.
• Complies with company, quality and safety standards, policies, and procedures.

This is not a remote position.

Must Have:

• 1+ years of relevant work experience
• Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
• Must be able to read, write, and speak fluent English.
• Must possess excellent verbal communication, organizational and management skills.
• Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
• Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
• ISO 13485 background
• Medical Device 21 CFR 820 knowledge
• Extrusion/Molding and/or manufacturing experience

Salary Range:

78,000 - 94,000 annual

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.