New employees are eligible for the following benefits effective date of hire!Medical, dental, and vision benefitsCompany-paid life insurance and disability benefitsGenerous Paid time off and 10 paid Holidays401k Plan with Company MatchTuition Reimbursement This position will be responsible for a number of Quality Engineering functions within the organization, primarily identifying and driving the resolution of internal and external quality issues. Activities include: participation in CAPAs; direct interaction with Operations, Customer Operations, and Engineering on technical issues and solutions; technical support of product development projects; support of process validations; support of customer, registrar, and other external audits; performing internal audits; and systemic improvements to the overall Quality Management System. Accountabilities & Responsibilities: Adhere to company Core Beliefs and all safety and quality requirements, including, but not limited to: company Quality Management System (QMS); Environmental, Health & Safety; company policies, procedures, and work instructions; and other relevant regulatory requirements. Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. Monitor manufacturing of assigned products, ensuring compliance with DMR and quality system requirements, and ensure complete and correct Device History Records are maintained. Identify, prioritize, and implement product and process improvement initiatives. Review the adequacy and correctness of changes to Bills of Material (BOM’s), Assembly Procedures, Drawings, Component Specification, PFMEAs, Control Plans, etc. Generate and lead the completion of protocols and reports for product, process, and test method validations. Recommend process monitoring devices where required and/or appropriate. Assist in writing and implementing Incoming, In-Process, and Final Inspection procedures. Ensure that the disposition of non-conforming materials comply with all relevant requirements, and ensure that appropriate corrective actions are implemented to prevent recurrence. Lead complaint investigations and manage appropriate remediation activities. Review quality data for potential CAPA’s, including analyses of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analyses. Assist with product transfers and new product development as required.Perform other functions as required. Position Requirements: Minimum Education: BS in Engineering or similar discipline.Minimum Experience: 0-2 years of Quality Assurance experience, preferably in a medical device manufacturing environment or other regulated industry. Knowledge & Skills: Experience with root cause analysis, DOE, statistics, lean manufacturing, trending, Risk Management, and/or Six Sigma methodologies preferred. Experience with Microsoft Office and Minitab desired. A winning attitude, strong interpersonal skills, and ability to live the “continuous improvement” philosophy and drive change within cross-functional teams. Ability to work independently with minimal direction. Ability to effectively communicate in both written and verbal form. Ability to manage time and priorities effectively to ensure on-time completion of tasks. Six Sigma Green Belt or Black Belt desired.Environmental Working Conditions: While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and will be required to wear safety glasses and shoes. The employee may encounter exposure to fumes, airborne particles or chemicals. The noise level in the work environment is usually low to moderate.