SMS - Quality Engineer
We are looking for a to join our Akron location for the 1st Shift schedules. You will be Responsible for quality engineering support of operations to ensure quality and operational goals are met. The Quality Engineer will utilize quality engineering principles and practice 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 nonconformances
- Support internal and external audits to maintain regulatory, customer and Avalign compliance.
- Coordinate Complaint, 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.
- Responsible for the development and execution of qualification and validation protocols. Summarizes results in reports.
- 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. Ensure employees are trained to do their work and their training is documented.
- Leadership - Must be able to lead teams; promote change; demonstrate high energy, trustworthiness and be goal oriented.
- Initiative – 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.
- Communication Skills - Good interpersonal and communication skills both verbally and in writing with superiors, colleagues, and individuals inside and outside the company.
- Technical Skills – Competent in Quality Engineering principles and practices including: developing sampling plans, statistical analysis, writing and executing validations, design of experiments, problem solving techniques, risk analysis, reliability testing , and technical writing. Technical Skills – Competent in Quality Engineering principles and practices including: developing sampling plans, statistical analysis, writing and executing validations, design of experiments, problem solving techniques, risk analysis, reliability testing , and technical writing.
- B.S. Degree in Engineering or Science. This position requires 3 plus years of relevant quality experience. ASQ certification (CQE, CRE, etc.) is considered a plus. Experience with Medical Device manufacturing is considered a plus.
- Requires effective computer skills including: Quality System Management software applications, Microsoft Office Software, statistical analysis (Minitab or equivalent), and project management. CAD and Lean/Six Sigma proficiency is considered a plus.
- 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
- Great 401k with company match
Avalign conducts a comprehensive background check that includes drug testing
- Pay Type Salary
- Akron, OH, USA