Cirtec Medical Corporation Brooklyn Park , MN 55443
Posted 3 weeks ago
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:
This position is primarily responsible with assisting quality engineers, quality control, and manufacturing
engineers in resolving quality issues in production. Individual responsibilities to be assigned at the discretion of the Quality Manager.
ESSENTIAL RESPONSIBILITIES:
reports.
Assist engineering with CAPA, Complaint and RMA investigations and verifications of effectiveness.
Interact when needed with customers and suppliers in support of engineering and production.
Write and edit process and procedural documentation as required.
Route Engineering Change Notices within Cirtec PLM system.
Perform process monitor checks and training audits.
Assist in performing internal audits.
Audit support for third party audits and customer audits.
Assist in maintaining documentation and approvals of suppliers.
Support QC with Incoming Inspection and DHR reviews.
Support the implementation of continuous improvement initiatives for production processes.
Ability to meet internal and external customer deadlines.
Operates effectively and maintains professionalism in an environment of deadlines and high
workloads and adjusts schedule or work hours to meet changes in priorities.
Able to perform the above duties with little to no supervision.
Provides technical knowledge regarding vision system programming (Zeiss, OGP, MicroVue) and measurement techniques.
Supports inspection and engineering teams with new inspection programs and performance of Gage R &R activities.
Complies with company, quality and safety standards, policies, and procedures.
Other duties as assigned.
WHAT YOU WOULD BRING:
Must be able to read, write and speak fluent English.
Minimum 4 years experience in medical/manufacturing environment.
Knowledge of Medical Device regulations (ISO 13485 and FDA 21CFR820).
Strong computer skills, including the MS Office suite.
Above average oral and written communication skills with in-house technical personnel and outside
vendors and customers.
Basic knowledge of engineering principles, technical writing, materials properties.
Ability to interpret technical drawings and technical documents
WHAT WE PROVIDE FOR YOU:
Health care and well-being programs including medical, dental, vision, wellness, and Employee Assistance program
Paid time off
Training and career development
Employee recognition program
Tuition assistance
401(k) retirement savings with a company match
Clean, climate controlled and well-lit production areas
HOURS:
4:30 am - 3:00 pm, Monday to Thursday
This is not a remote position.
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 an individual encounters while performing the essential functions of this 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.
Cirtec Medical Corporation