Support R&D Design Control Process, Process Development, Process Validation, Test Method Validation and manufacturing with an emphasis on product quality. Critical attributes and skills include creativity, initiative, detail oriented, ability to prioritize and negotiate priorities, hands on approach, and also multi-tasking. The Quality Engineer performs a variety of duties that involves engineering analysis and problem solving. This role will also participate in the areas of material control and flow including inspection.
ESSENTIAL JOB RESPONSIBILITIES
Performs risk management processes and root cause investigations.
Oversees the disposition of non-conforming material and processes.
Designs and executes continuous improvement projects to reduce process variation and eliminate quality problems.
Evaluates product returns and assists in complaints investigation and closure.
Performs trending of established quality metrics.
Conducts audits (internal, ISO, FDA, and supplier) as needed.
Provide quality engineering input and guidance to Product and Process Development process for new products, product changes and enhancements.
Support manufacturing operations and supplier quality management.
Designs and/or reviews and approves equipment and process validations: Installation Qualification of equipment, Operational Qualification (OQ) and Performance Qualification (PQ) of new processes.
Develop new test methods and perform test method validation in compliance with FDA and ISO requirements.
Create and support the quality documentation system in compliance with FDA and ISO requirements under the direction of the quality management.
Support training programs as part of the quality documentation system.
Plan and schedule projects in a manner consistent with corporate objectives.
Work with product development staff to ensure that products under development are compliant with FDA and ISO requirements.
EDUCATION & EXPERIENCE
B.S. in Industrial Engineering, Mechanical Engineering, or Bio-Medical Engineering or equivalent experience with college degree (BS or BA).
Minimum 3-5 years related industry experience.
Strong knowledge of statistics and experience with demonstrated application of statistics in a medical device development and manufacturing environment required. DOE, SPC, hypothesis testing, etc.
Must possess excellent written and verbal communication skills.
Working knowledge of inspection tools such as: calipers, micrometers, snap gage, microscope, tensile tester, VIS and pin gages.
Product testing experience and reporting
Experience with the validation of medical device manufacturing processes (IQ/OQ/PQ)
Experience with medical device design controls
Intermediate level skill in Microsoft Word, Excel, Outlook and other office software programs.
Knowledge of Solidworks is a plus.
Lean and Six-Sigma experience a plus.