Our client in the Suffield, CT area is looking to add an experienced Sustaining Quality Engineer to their growing team. Candidates interested should have experience working in a regulated manufacturing environment (i.e. ISO9001, ISO13485). Medical Device experience is also highly preferred. If you are interested in learning more please apply below and call us today for immediate consideration. Thank you.
location: Enfield, Connecticut
job type: Permanent
salary: $70,000 - 80,000 per year
work hours: 8am to 4pm
education: High School
- Provide Quality Engineering support for engineering project development.
- 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 investigations and in support of manufacturing.
- Provide Quality Support for the disposition of material.
- 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.
- Comply with all work rules including those pertaining to safety, health, quality and Cirtec policies.
- Back up to Quality Systems Administrator.
- Perform other duties as necessary.
- Experience level: Experienced
- Minimum 5 years of experience
- Education: High School (required)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.