Avalign Cutting Instruments has established itself as a leading manufacturer of high quality surgical drills and precision instruments in the medical device marketplace. While specializing in precision-machined cutting instruments for the orthopedics industry, we also provide support for the orthopedic device market with a particular focus on segments experiencing high growth and innovation. Our defining strengths are engineering support, cutting geometry design, product development support, and the overall cutting performance of the instruments we manufacture. We are currently looking for a Quality Engineer for our Warsaw, Indiana facility. If you have the qualifications included below and would like to join a growing team in a fast-paced environment, then please apply in person or via email to email@example.com
Responsible for quality engineering support of operations to ensure quality and operational goals are met. The QE will utilize an engineering approach to improve manufacturing efficiencies and the quality of all products while reducing manufacturing costs.
Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
May develop mathematical models to identify units, batches or processes posing excessive failure risks.
Utilize standard statistical analysis and problem solving techniques to determine product acceptance and evaluate process capabilities.
Conducts or guides testing and data analysis which demonstrate that new processes meet acceptance criteria
Quality lead for customer-based advance planning of new product launches, legacy product maintenance and customer related change control
Primary quality representative for site supplier management and resolution of supplier nonconformance
Support internal and external audits to maintain regulatory, customer and Avalign compliance.
Coordinate CAPA and SCAR investigations and closures in compliance with regulatory, customer and Avalign requirements
Participate in Material Review Boards.
Responsible for the development and execution of qualification and validation protocols.
Establish and support a work environment of continuous improvement that supports Avalign Medical’s Quality Policy, Quality System, and the appropriate regulations for the areas they support.
To perform the job successfully, an individual should demonstrate the following:
Must be able to lead teams; promote change; demonstrate high energy, trustworthiness and be goal oriented
Must Be a 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 in writing with superiors, colleagues, and individuals inside and outside the company.
Requires effective computer skills; Microsoft Office Software and other company and discipline specific software applications (Minitab or equivalent). CAD and Lean/Six Sigma proficiency is considered a plus.
Experience & Aptitudes:
Minimum of 5 years in medical device manufacturing as a QE or QA – CQE/CQA a plus.
2 or 4-year Technical degree preferred.
Well versed in all aspects of FDA CFR 820 and ISO 13485 regulatory compliance requirements.
Ability to adapt to changing needs and handle multiple responsibilities in a fast-paced environment.
Proficient in the Microsoft Office suite of software.
Previous Master Control experience a plus.