DescriptionPosition Summary: 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.
Key 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.
- Complies with company, quality and safety standards, policies, and procedures.
This is not a remote position.Must Have:- Bachelor's degree in engineering discipline
- 1+ years of relevant work experience
- 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.
- Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
- ISO 13485 background
- Medical Device 21 CFR 820 knowledge
- Extrusion/Molding and/or manufacturing experience
Salary Range: 78,000 - 94,000 annual
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.
