Quality Engineer I

Job Title:

Quality Engineer I

Supervisor’s Title:

Quality Engineering Manager

Division:

Quality Assurance

Department:

Quality Engineering

PRINCIPAL RESPONSIBILITIES

Essential functions include, but are not limited to:

• Provide Quality Engineering project support for NPD and transfer to manufacturing.
• Provide Quality Engineering technical support to assist in resolving quality issues.
• Analyze process/product non-conformances and implement comprehensive corrective and preventive action plans.
• Prepare, execute, and analyze validations to approve equipment, processes, and software used in the testing, processing, storing, and distribution of products.
• Collect, statistically analyze, and develop report packages to support validations and engineering studies.
• Assist in the development, implementation, and documentation of qualifications/validations to ensure that the products processed are proven to be reliable, safe, and effective prior to release.
• Effectively complete “other” functions that may be assigned.

• QE duties include:

• Partner with R&D and other cross functional groups to support successful development and commercial launch of new products.
• Partner with R&D and other cross functional groups to support the proper application of design controls, risk management, and the investigation/correction of design failures/challenges. 
• Accountability for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls etc. including assessing, applying and interpreting acceptance sampling for manufacturing data. 
• Assist in Development of Risk Management Documents to include FMEA’s.
• Review, approve, and validate Test Methods.
• Interface with manufacturing facilities as required.
• Conduct investigations, bounding, documentation, and review of non-conformances, CAPA’s and customer complaints as necessary.

KEY RESULT AREAS

• Assist in the implementation of corporate policies and procedures relating to quality, project management, process development, and cGMP/ISO compliance by periodically reviewing specifications for functionality and initiating the required changes, establishing procedures and integrated program plans for achieving reliability in accordance with specifications and procedures.

• Ability to execute, and analyze validations to approve equipment, processes, and software used in the testing, processing, storing, and distribution of products.
• Ability to interact effectively with people at all levels throughout the company.

QUALIFICATIONS

• Minimum of a Bachelor’s Degree in engineering field or equivalent experience.
• Minimum of 1 year hands-on experience; preferably in a FDA regulatory industry (i.e., pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards.

OTHER FACTORS OF JOB PERFORMANCE

• Personal computer skills, i.e., word processing, spreadsheets, data analysis.
• Must have high degree of stability, good emotional control, good interpersonal skills, and excellent expression (both oral and written).
• Must be open-minded, flexible, and able to adapt easily and accept new ideas quickly.

• Must be able to maintain a high activity level and be able to effectively manage and prioritize numerous projects and responsibilities.