Supplier Quality Engineer

Responsible for ensuring that the quality of products being supplied to the organization meet the prescribed quality levels. Performs Quality Assurance activities including review of manufacturing and supplier quality inspection documentation. 

 

• Essential Duties and ResponsibilitiesMonitors the Supplier quality system including records and results from processes and procedures to ensure product Quality and compliance.

• Sets the standard for QA documentation review for Supplier Quality regarding quality review of thoroughness and timeliness.

• Schedules and manages Supplier Audit schedules and metrics in order to ensure batch record reviews are conducted in a timely manner.

• Ensuring supplier quality documentation is accurate, maintained, and reflects GMP, procedural and regulatory requirements. 

• Provides constructive feedback to QA and Operations staff regarding documentation quality.

• Inspect and test processes and procedures – take measurements and compare to a predefined standard.

• Maintain knowledge of current regulatory requirements pertaining to drug/device manufacturing and communicates requirements to other associate staff. 

• Perform and trains others on label control functions

• Participate in investigations of quality issues as required.  Provides analysis and trend information to support these activities.

• Accurately documents results of inspections and tests, and trains other associates on these supplier quality activities.

• Monitor KPIs and perform data trending for supplier quality metrics.

• Support and coordinate Quality Operations functions for Supplier Quality.

• Review Standard Operating Procedures (SOPs) for manufacturing and supplier quality processes.

• Participates in continuous improvement objectives to assure compliance with regulations.

• Develops and/or maintains metrics and trending reports for compliance related activities.

• Supports internal audits and regulatory inspections.

• Train production team on quality procedures, protocols, and documentation as needed.

• Lead and Mentor Quality personnel, including promoting quality culture and supporting quality objectives.

• Other related duties as assigned.

• College degree required, preferably in a scientific discipline.

• 5+ year experience in FDA/cGMP regulated environment.  FDA 21CFR210/211/820 and ISO14845.

• Technical knowledge and experience with measuring and testing equipment such as calipers, micrometers, vision systems, optical comparator, voltmeter, pin gauges

• Strong analytical and communication skills with keen attention to detail. 

• Must have strong organization skills with attention to detail and accuracy.

• Proficiency in the use of MS Word, Excel and Outlook. MS Access and other software tools, a plus.

• Must have good basic mathematical skills

• Fluent in English (verbal and written); fluency in other languages is a plus

• Physical Demands

• Occasionally required to climb, bend, stoop, kneel. 

• Required to stand for long periods of time. 

• Occasionally required to lift, push, carry, and/or move items weighing more than 50 lbs.