Production Quality Engineer

The Job Responsibilities

The Production Quality Engineer ensures that all assembly processes and documentation comply with the quality system and to Current Good Manufacturing Practice. Supports investigation & monitoring of supplier quality related issues in production. Collects all production process and product related quality figures (TOP 15, PFR, etc.). Provides all quality related product & assembly process documentations according to FDA & ISO requirements. Ensures that all processes, tools, equipment, documentations, employee skills & the verification & validation processes comply with internal procedures and standards, FDA, GMPs, NIOSH, & ISO standards & requirements. Support production in the areas of Traceability entry, archiving, and Shelf-Life controls.

• Measures, monitors and trends key metrics for the control of the production quality system.

• Creates reports as required for Quality Management reviews, or for problem solving/analysis and continuous improvement activities.

• Assist with quality-related activities in the following areas; MRB (Material Review Board), CAR's (Corrective Action Requests), CAPA (Corrective and Preventive Actions), Production support, Quality Management Reviews, Quality Audits and other associated tasks.

• Assist in supporting all quality related product and assembly processes. E.g. FMEA, verification and validation, production tools, equipment, and documentation, according to FDA, GMP, NIOSH, and ISO standards and requirements

• Provide support, as needed, to the incoming inspectors with quality-related issues and answer inspection questions.

• Provide guidance and updates about issues found on the production floor to the incoming inspection department.

Production Line Responsibilities:

• Record, report and disposition non-conformances discovered in production.

• Daily support to "keep production running" regarding all types of quality-related issues.

• Train production personnel on traceability data entry and troubleshoot errors.

• Troubleshoot master data issues related to shelf-life controls.

• Training personnel in quality related SOPs.

Help to support the development of production equipment/process specifications, and their verification and validation:

• Creation of training instructions and monitoring of employee trainings.

• Handling of nonconformance material issues & coordination of MRB meetings.

• Release/Initiate deviation permits relating to parts & processes in production.

• Performs other duties as needed and assigned.

Your Qualifications

Education:

Bachelor of Science Degree in a Quality Management, or in an Engineering field with a strong Quality background.

Related Experience:

3 - 5 years working in a Quality Control / Assurance area. Experience in the Medical Device Industry and an understanding of the FDA/GMP, and ISO preferred. Strong working knowledge of SAP preferred. (Quality Management Module)

Special Competencies:

• Demonstrates strong analytical, problem-solving skills.

• Strong written and verbal communication skills.

• Detail oriented, good organizational traits.

• Self-motivated