Quality Engineer

Cicor Group; Solon (OH); On-site; USD 70,000 - 100,000; Full time

Job summary

Cicor Solon, OH is seeking a Quality Engineer to provide quality assurance support to the product development team and resolve defects to ensure customer specifications are met.

Responsibilities include maintaining ISO 13485 compliant processes, leading quality investigations, and ensuring regulatory compliance across manufacturing, NPD, and suppliers. Strong communication and cross-functional collaboration are essential.

Qualifications

• Higher education degree or 5 years work experience in lieu of degree.
• Medical Device experience required including knowledge of FDA regulations.
• Excellent written and oral communication skills.
• Prolonged periods of sitting at a desk and working on a computer.

Responsibilities

• Understand ISO 13485:2016 requirements (FMEA, CAPA, Root Cause Corrective Action).
• Create and maintain quality metrics and execute design controls.
• Lead quality investigations and CAPA activities.
• Support manufacturing and NPD to ensure regulatory compliance.
• Communicate across R&D, Manufacturing, Supply Chain and Customer Service.

Skills

Communication

Organization

Analytical thinking

Cross-functional collaboration

Problem solving

Education

Bachelor's degree or 5 years experience in lieu of degree

Tools

Microsoft Office

Excel

Word

PowerPoint

Job description

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.

Quality Engineer

Key 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.

Person Specification

• 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.
• Proficient with Microsoft Office Suite or related software.

Education And Experience

• Higher education degree or 5 years work experience in lieu of degree.
• Handle various projects and responsibilities simultaneously and successfully meet deadlines.
• Microsoft Excel/Word, and PowerPoint. Work with other groups or individuals to resolve issues.
• Medical Device experience required to include ISO 13845:2016 including Knowledge of
• FDA regulations
• Excellent written and oral communication skills.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift upto 15 pounds at times.