Quality Engineer

About the role

Be the engineering force behind quality and continuous improvement! Cicor Solon, OH is seeking a Quality Engineer to provide quality assurance support to the product development team, resolve defects and any other issues to ensure that products meet customer specifications.

Responsibilities

• Understanding of ISO 13485:2016 requirements, (e.g. FMEA, CAPA, Root Cause Corrective Action and Customer Feedback).
• Create and maintain quality Metrics when assigned
• Execute design controls and analyze design inputs.
• Purchasing and Supplier controls
• Implementing receiving inspection criteria.
• Develop and implement Data Analysis metrics.
• Leads investigations related to quality problems.
• Ability to define and manage risk-management plan, risk assessment and risk-control tools.
• Facilitate or independently lead non-conforming product investigations, including corrective/preventive actions and product remedial actions.
• Responsible for systems assurance including documentation, testing and inspection, and product and process development.
• Will support Manufacturing, New Product Development, and Regulatory (as applicable) to ensure systems are in compliance with internal and external guidelines and regulations.
• Identify and lead product and systems continuous improvement initiatives.
• Communicate effectively at all levels within Quality, as well as cross-functionally with R&D, Manufacturing, Supply Chain, Customer Service, Sales, and other functions as necessary.
• Able to influence decisions in a cross-functional team setting.
• Knowledge Equipment Qualification Experience (IQ/OQ/PQ).
• May participate in internal/external audits.
• QE-NPD Focus Lead and support new product development execution of design control from concept through post-launch phases.
• Support design change activities through product lifecycle.

Requirements

• Higher education degree or 5 years work experience in lieu of degree.
• Handle various projects and responsibilities simultaneously and successfully meet deadlines.
• Medical Device experience required to include ISO 13845:2016 including Knowledge of FDA regulations.

Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.

Qualifications

• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Extensive knowledge of or the ability to quickly learn the organization’s production processes.
• Excellent interpersonal skills with ability to serve as a liaison with developers, project managers, and customer support.
• Strong analytical and problem-solving skills.

Skills

• Proficient with Microsoft Office Suite or related software.
• Microsoft Excel, Word, and PowerPoint.