Quality Technician I - Cirtec Medical Corporation

This position is eligible for a $2,250 Sign-On Bonus

WHO WE ARE:

For over three decades, Cirtec has been an industry-leading outsource partner for complex medical devices. Cirtec Medical provides outsourcing solutions for Class II and III medical devices. From design and development, to precision components and finished device assembly, Cirtec can help bring complex devices to market. Cirtec's expertise includes neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

OUR PEOPLE:

The key to our success is our employees. The extensive design, development and manufacturing experience they provide enables us to create cost-effective, innovative medical device solutions for our customers. Our creative and innovative staff are expert problem solvers and understand the technical, practical and regulatory issues involved in bringing a new or next-generation product to market.

WHY WORK FOR CIRTEC:

With three locations in Brooklyn Park, MN, our employees have the satisfaction of knowing that the work they do helps patients live better, longer lives and their commitment and expertise have made the company it is today: An industry leading provider of life enhancing therapies.

JOB SUMMARY:

The Quality Technician is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, and quality systems.

ESSENTIAL RESPONSIBILITIES:

• Under Quality Engineer (QE) oversight, assist with qualification and validation (IQ, OQ, PQ).
• Compile and analyze statistical data to assess process capabilities and control processes.
• Develop inspection test methods and draft inspection procedures with QE oversight.
• Handle Calibration Management including new and current equipment that requires calibration, calibration supplier management and out of tolerance reporting as required.
• Handle Environmental Monitoring Management including collecting samples, testing, entering, and trending results and out of tolerance reporting as required.
• Support the nonconforming material reporting process including verifying nonconformance descriptions, evaluating to determine root cause of the nonconformance and proposing final disposition of nonconforming product.
• Review and approve inspection and device history records as required.
• Support CAPA process by assisting in the investigation and implementation of corrective action.
• Identify areas of improvement and participate in continuous improvement projects.
• Perform Gemba walks and participate in 5S activities.
• Support QEs.
• Complies with company, quality, and safety standards, policies, and procedures. • Other duties as assigned.

This is not a remote position. An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

QUALIFICATIONS:

• High School diploma.
• 1 year of experience in manufacturing environment (preferred requirement - Medical Device industry).
• Knowledge of medical device regulations (21CFR820, ISO 13485).
• Technical training and/or experience in related field.
• Working knowledge of basic inspection processes and measurement practices.
• Must be able to read, write and speak fluid English.
• Ability to read and interpret assembly drawings and specifications.
• High proficiency in use of computer systems using standard business software: Outlook, Word, PowerPoint, Excel, MRP/ERP systems.
• Strong verbal and written communication skills.
• Ability to work with a wide variety of functional areas including but not limited to Program Management, R&D, Manufacturing and QA as required.
• Excellent organization and time management skills with an ability to think proactively and prioritize work.
• Flexible and able to accommodate changing priorities and directions.

WHAT WE PROVIDE FOR YOU:

• Health care and well-being programs including medical, dental, vision, wellness, and Employee Assistance programs
• Paid time off
• Training and career development
• Employee recognition program
• Tuition assistance
• 401(k) retirement savings with a company match

WORKING ENVIRONMENT:

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those individual encounters while performing the essential functions of this position.

This is not a remote position

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

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.