Production Quality Engineer

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.

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

Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.

Our US headquarters located north of Philadelphia in Telford, Pennsylvania is our US manufacturing site for our Neonatal product line supplying many global customers as well as production support for Draeger’s Safety products. This location also serves as the key site for essential US functions which includes Medical Sales and Service Management, Medical Marketing, Legal, Compliance, Regulatory, Quality and Finance.

EEO is the Law

Draeger is an Equal Opportunity Employer. To learn more: Know Your Rights: Workplace Discrimination is Illegal (dol.gov)

From hospitals to fire departments to industrial customers, people around the world rely on our products: cutting-edge technology that combines real engineering with the digital future. With over 130 years of experience, passion and the bold ideas of more than 16,000 employees, we are committed to turning technology into ›technology for life‹.