As a Quality Engineer, you will play a vital role in helping the company achieve its production and quality objectives. By applying engineering principles, you will work to boost manufacturing efficiency while ensuring that every product consistently meets our rigorous quality standards. Your Responsibilities Lead the development of inspection plans within the manufacturing environment. Guide engineering and production teams through validation planning and NPI transfers to help ensure all project requirements are successfully met. Deliver continuous quality engineering support across the product lifecycle, covering design changes and CAPA investigations. Serve as the main quality point of contact for managing suppliers and resolving any nonconformance issues. Assist with internal and external audits to help maintain full compliance with customer, regulatory, and Avalign standards. Oversee the Non-Conforming Material Reports system and manage the final disposition of all non-conforming items. Strengthen and manage product risk activities to ensure all identified mitigations are fully implemented. Engage in technical reviews and contribute to risk-based decision-making processes. Propose and implement enhancements to manufacturing processes and quality systems to foster a culture of continuous improvement. Develop robust corrective action plans and lead the execution of quality assurance strategies to exceed internal and external benchmarks. Suggest appropriate test methods and statistical process controls to ensure high levels of product reliability. Execute or oversee data analysis and testing, including Gage R&R and capability studies, to verify that new processes satisfy acceptance criteria. Act as the primary Quality Engineering liaison for designated projects and clients. Provide supervision for quality inspectors or technicians at the manufacturing site as required. Represent quality interests in assigned areas, ensuring adherence to

ISO 13485, FDA

regulations, and internal Avalign procedures. Collaborate with engineering and operations teams to ensure the Material Review Board process is consistently followed. Provide ongoing operational support, including the development of inspection requirements and investigation of complaints, NCs, and CAPAs. Prepare and submit necessary documentation for both new product launches and legacy product inquiries. Core Competencies Direct assigned teams in the creation of quality-focused initiatives and processes. Track complaint data and trends to ensure that emerging issues are escalated and addressed in a timely manner. Design and deploy effective process controls to support product development and ongoing manufacturing, ensuring all internal and external requirements are satisfied. Required Qualifications A Bachelor of Science in an engineering discipline combined with a minimum of 5 years of manufacturing experience, or an equivalent mix of education and professional background. Strong preference for candidates with a background in process development or new product introduction within a manufacturing setting. Familiarity with regulatory requirements such as 21CFR820 and quality standards like

ISO 13485.

Proficiency in interpreting blueprints, along with a solid grasp of inspection techniques and GD&T. Ability to apply problem-solving methods and statistical analysis to evaluate process capabilities and determine product acceptance.

Required Proficiencies:

5 Why (Root Cause Analysis Method) FDA Regulations