Quality Engineer

Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce. We are looking to hire a Quality Engineer for our facility in Fort Wayne, Indiana! Job Scope: Responsible for owning and executing quality system processes in support of quality objectives. The Quality Engineer will utilize a data driven approach to define or improve quality systems, quality processes or overall product quality. Duties/Responsibilities: Facilitate or perform documented customer complaint investigations and complete any required customer responses. Quality lead for customer-based planning of new product launches, legacy product maintenance and customer related change control. Typical responsibilities include but are not limited to revising existing or creating; Control Plans, pFMEA, Gage R/R, final product acceptance inspection plans, and performing process capability studies in addition to meeting customer specific deliverables. Primary quality representative for site supplier management and resolution of supplier nonconformances. Support internal and external audits to maintain regulatory, customer and Avalign procedure compliance. Coordinate CAPA and SCAR investigations and closures in compliance with regulatory, customer and Avalign requirements. Participate in Material Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigate and analyze customer/internal complaints for trends and potential improvements. Responsible for the development and execution of qualification and validation protocols. Summarizes results in reports. Utilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities. Establish and support a work environment of continuous improvement that aligns with Avalign’ s Quality Policy, Quality System, and the appropriate regulations for the areas they support. Other duties as assigned. Competencies/Essential Functions: Self-starter, open-minded, willing to learn new ideas, desire to drive change and improve current standards and be a team player Good interpersonal and communication skills both verbally and I writing with superiors, colleagues, and individuals inside and outside the company Experience leading or managing a quality group or department Measurement system programming experience preferred Previous medical device inspection experience Attention to detail Ability to work with little direct supervision Knowledge of ERP scheduling system Knowledge of Microsoft Excel, Word, and Outlook Knowledge of Minitab, gauge tracking software CAD and Lean/Six Sigma proficiency is a plus Education and/or Experience: Bachelor’s Degree in engineering discipline Three (3) plus years of relevant quality experience Experience with Medical Device manufacturing preferred What You'll Enjoy: Competitive wage and benefits package Vacation, make-up time, and immediate eligibility for paid holidays Medical, dental, and vision insurance Life and AD&D insurance, disability insurance 401(k) Retirement Plan We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. www.avalign.com Job Type: Full-time Benefits: 401(k) Dental insurance Health insurance Paid time off Vision insurance Schedule: 8 hour shift Application Question(s): What interested you in the position at Avalign? What are your salary requirements? Work Location: In person