Quality Engineer I

Cirtec Medical Corporation • Brooklyn Park, MN

42d • $65,000 - $80,000 • Onsite

About The Position

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.

Requirements

• Bachelors 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.

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 NCRs.
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Miscellaneous Manufacturing
• Number of Employees: 101-250 employees