Quality Engineer III - Intellectt INC

Role: Quality Engineer III

Location: Mansfield, MA - 2048

Duration: 12 Months

Primary responsibilities are to:

EUMDR Class II & III Compliance Projects

Works in a cross-functional team to assess Supplier Validations and general documentation for compliance to EU MDR requirements and perform required remediation activities.

Works with supplier base to identify gaps to EU MDR requirements, specifically related to Process Validation.

Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

Conduct benchmarking to develop more effective methods for improving quality.

Approve IQ, OQ, PQ, TMV or Software Validations.

Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.

Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.

Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.

Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process. It is also understood that an associate may receive special projects outside of this list

DESIRED MINIMUM QUALIFICATIONS:

Minimum required education and experience: Bachelor's degree or equivalent with 8+ years of experience, Master's degree with 5+ years of experience, Doctoral degree with 3+ years of experience

This position will require relevant experience working in manufacturing/operations. In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.

Experience with a proven track record of implementing appropriate risk mitigation.

Good technical understanding of manufacturing equipment and processes is required. Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.