Cirtec Medical · 8 hours ago
Quality Engineer I
Brooklyn Park, MN
Full-time
Onsite
Entry Level
$65K/yr - $80K/yr
1+ years expCirtec Medical is a leading outsourcing partner for complex medical devices, specializing in comprehensive solutions for Class II and III devices. The Quality Engineer I position is primarily responsible for monitoring and auditing the quality of manufactured goods, identifying defects, and developing solutions while supporting engineering projects.
ManufacturingMedical Device
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
Qualification
Required
Bachelor's degree in engineering discipline
1 year of experience; or a combination of work and internship experience
Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement
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
Benefits
Training and career development
Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid Time Off
401(k) retirement savings with a company match
Company
Cirtec Medical
Stellar Technologies is manufacturer of precision components and assemblies.
1001-5000 employees
H1B Sponsorship
Cirtec Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (4)
2022 (2)
2021 (3)
2020 (8)
Funding
Current Stage
Late StageTotal Funding
unknown2016-08-01Acquired
Leadership Team
Ed Philbin
Chief Financial Officer
Recent News
2025-10-02
2025-09-17
2025-08-29
Company data provided by crunchbase