Essential Duties/Responsibilities:

• Ensure operational processes and quality requirements meet customer expectations, update as required and clarify customer requirements when necessary.
• Provide support to engineering, inspection, manufacturing, purchasing, and sales functions to achieve SPG team goals.
• Assist in the project development phase of products by specifying first article submission requirements. This includes dimensional analysis, capability studies, customer forms, and required certifications.
• Initiate corrective/preventive action when necessary.
• Process incoming, in-process, finished, and customer returned discrepant material according to the Non-Conforming Material and Corrective Action procedures.
• Support MRB meetings for rejected product.
• Support the problem resolution process by acting as resource for quality problem solving methodology.
• Respond with documented closed loop corrective action to internal and external quality problems when appropriate.
• Lead and/or support continuous improvement efforts including 5S.
• Participate in CAPA root Cause investigation and action implementation.
• Prepare Quality related deliverables in a timely manner.
• Perform process and internal ISO audits.
• Prepare and execute Engineering and Gage R and R studies as required.
• Work directly with all levels of the organization to ensure conformity to standards (ISO 13485)
• Perform training within all levels of the organization.
• Create and maintain quality/inspection documents.

Position Requirements:

• Applicable Bachelor’s degree and/or equivalent experience in a related field, and elated experience. Quality Assurance experience preferred.
• Proficient in applicable quality principles including, but not limited to, statistics, sampling management, metrology, quality planning techniques, and closed loop corrective action.
• Ability to problem solve, identify errors and deficiencies and perform research with limited guidance.
• Ability to apply knowledge to job function using pre-established guidelines and instructions.
• Accuracy, attention to detail, and thoroughness.
• Proficient communication skills.
• Proficient M/S Office computer skills, experience with Minitab is a plus.
• Ability to comprehend and comply with company safety and quality standards.
• Ability to follow oral and written instructions.
• Ability to work within a Team orientated fast paced environment.
• Familiar with Six Sigma, lean manufacturing, PFMEA, Process Control Plans, Process Risk Management and Product Qualification protocols.
• Medical Device experience (specifically ISO 13485, GDP and QSR) and knowledge of Clean Room requirements preferred