Quality Engineer

Primary Duties and Responsibilities

• Assist in the development and review of Purchasing Specifications and receiving inspection criteria as new products are brought on line.
• Responsible for gaining a comprehensive understanding of the manufacturing process prior to transfer to manufacturing and for assisting in the transfer to manufacturing through training of QA inspection and manufacturing personnel.
• Develop and maintain verification and inspection procedures, methods, and sampling plans to assure customer requirements and product specifications are met.
• Lead in the development and maintenance of Limit Samples and other inspection aids
• Lead all Risk Assessment activities
• Lead QA Specialists in the Nonconforming Materials Control Process by assuring non-conformances are investigated, controlled, documented, resolved and closed in a proper and timely manner
• Perform investigations and document findings related to Corrective Action and Preventive Actions that are initiated. Performs follow-up verifications after CAPA Plans are implemented
• Evaluate, summarize and report on quality data and Key Performance Indicators to assure problems are being adequately addressed and there are no indications of trends or system breakdowns.
• Provide support to other Managers and Engineers related to Cost Savings and continuous improvement Initiatives
• Provide interface and communications with customer and suppliers on all quality concerns.
• Develop and maintain training modules and training effectiveness assessments related to quality procedures and practices
• Review and approve Validation Protocols and Reports
• Assist in the execution of Validation activities as required.
• Interfaces with Suppliers regarding incoming quality issues
• Performs Supplier Audits
• Conducts Internal Audits
• Other duties as assigned

Required Qualifications

• 4 year BS degree or equivalent applicable experience
• Proficient in the use of Quality Management Tools
• Proficient in MicroSoft Office Suite
• Strong writing skills
• Strong verbal communications skills
• Proficient in interpretation of regulatory requirements and standards
• Strong Analytical skills - Cause and Effect Analysis

Preferred Qualifications

• ISO 9001 or ISO 13485 Certified Auditor
• Experience in the performance of Supplier Audits / Evaluation
• Experience in the appropriate selection of Statistical Tools

Environment & Working Conditions

• Lifting - 30 lbs
• Ability to work in a cleanroom environment
• Standing for long periods of time
• Bending
• Sitting for long periods of time
• Visual - Constant Visual attention

Primary Duties and Responsibilities

• Assist in the development and review of Purchasing Specifications and receiving inspection criteria as new products are brought on line.
• Responsible for gaining a comprehensive understanding of the manufacturing process prior to transfer to manufacturing and for assisting in the transfer to manufacturing through training of QA inspection and manufacturing personnel.
• Develop and maintain verification and inspection procedures, methods, and sampling plans to assure customer requirements and product specifications are met.
• Lead in the development and maintenance of Limit Samples and other inspection aids
• Lead all Risk Assessment activities
• Lead QA Specialists in the Nonconforming Materials Control Process by assuring non-conformances are investigated, controlled, documented, resolved and closed in a proper and timely manner
• Perform investigations and document findings related to Corrective Action and Preventive Actions that are initiated. Performs follow-up verifications after CAPA Plans are implemented
• Evaluate, summarize and report on quality data and Key Performance Indicators to assure problems are being adequately addressed and there are no indications of trends or system breakdowns.
• Provide support to other Managers and Engineers related to Cost Savings and continuous improvement Initiatives
• Provide interface and communications with customer and suppliers on all quality concerns.
• Develop and maintain training modules and training effectiveness assessments related to quality procedures and practices
• Review and approve Validation Protocols and Reports
• Assist in the execution of Validation activities as required.
• Interfaces with Suppliers regarding incoming quality issues
• Performs Supplier Audits
• Conducts Internal Audits
• Other duties as assigned

Required Qualifications

• 4 year BS degree or equivalent applicable experience
• Proficient in the use of Quality Management Tools
• Proficient in MicroSoft Office Suite
• Strong writing skills
• Strong verbal communications skills
• Proficient in interpretation of regulatory requirements and standards
• Strong Analytical skills - Cause and Effect Analysis

Preferred Qualifications

• ISO 9001 or ISO 13485 Certified Auditor
• Experience in the performance of Supplier Audits / Evaluation
• Experience in the appropriate selection of Statistical Tools

Environment & Working Conditions

• Lifting - 30 lbs
• Ability to work in a cleanroom environment
• Standing for long periods of time
• Bending
• Sitting for long periods of time
• Visual - Constant Visual attention