Quality Engineer

The Quality Engineer is responsible for development and implementation of production quality control.  The role will work closely with operations and product engineering to reduce scrap and drive continuous improvement activities within the manufacturing process to reduce customer complaints. This position will investigate internal and external quality issues, identifying root cause and corrective actions.  The position will be responsible for using data analysis, data trending and periodic reporting. This position will perform process validations (IQ, OQ, PQ) and may support testing associated with product design verification or validation. This role will also support the Design and Development activities as the Quality representative for products throughout the lifecycle. 

Key Responsibilities: 

• Assess, plan, and perform required process validations in support of Operational activities and changes.  This includes management of all required activities and documentation associated with the IQ, OQ, and PQ within the Quality Management System.
• Perform discrepant material disposition with guidance.
• Develop inspection plans, test methods, and standard operating procedures.
• Conduct sample size determination, statistical analysis, root cause analysis and applicable training.
• Participate and actively contribute within a cross-functional team on various manufacturing projects such as process development, cost reduction and quality improvement initiatives.
• Collect and trend quality indicators for required reviews. Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
• Review internal quality catch issues and provide dispositions.
• Review supplier and material nonconformance reports and provide dispositions.
• Support documentation development including writing specifications for manufacturing or scientific test results.
• Participate and support in the Internal and External Audit process and assist in addressing requests, observations, and non-conformances.
• Analyze equipment test results.
• Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.
• Participate as the Quality representative in design control activities for New Product Development and Product/Process changes, with responsibilities in process control, risk management and oversight of product specifications.
• Support investigation and communication to customers regarding product concerns.

Qualifications, Education & Experience:

• Bachelor of Science degree in engineering field (required) with at least two years of experience in medical device development/manufacturing (preferred).
• Demonstrated experience with authoring and managing manufacturing process validations, completion of IQ, OQ, PQ per medical device requirements and guidance.
• Strong analytical skills with an ability to use scientific knowledge and statistical methods to identify issues and assess the acceptability of system and process performance.  Demonstrated knowledge and understanding of Statistical Process Controls.
• Experience with Corrective and Preventive Action process.
• Knowledge and understanding of ISO 14971 and risk management implementation.
• Strong communication, organization, project management, and time management skills are necessary, as well as strong interpersonal skills, and being team oriented with a positive attitude.
• Ability to prioritize work per business needs in a fast-paced environment.
• High degree of accuracy and attention to details.
• Must have excellent problem-solving skills.
• Ability to make decisions based on expertise and customer/business requirements.
• Ability to perform essential functions and responsibilities with little to no supervision.
• Excellent written and oral communication, technical writing and editing skills.
• High proficiency in the use of Microsoft Office (Word, Excel, PowerPoint, etc.) and Adobe.
• LEAN/6 sigma experience (preferred).
• Knowledge and experience in interpretation of drawings, specifications, blueprints, etc.
• Demonstrated experience using inspection and measuring instruments such as calipers, micrometers, tensile strength testers (e.g. Instron), etc.
• Able to follow instructions in all formats: written, verbal, and electronic.