DescriptionPosition 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.
Key Responsibilities:- Provide quality support in dispositions of materials along with completing non-conformance 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.
Must Have:- Associates of Science or equivalent, preferably in an engineering discipline.
- Must be able to read, write and speak fluent English.
- Minimum 4 years' experience in medical/manufacturing environment.
- Minimum 4 years' experience in quality inspection
- 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.
Salary Range is between 35 and 46 per hour based on skills and experience.
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.
