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Quality Engineer – Medical Devices

We are currently searching for an experienced Quality Engineer who will be responsible for maintaining our quality system and ensuring product quality at every stage of the production process. In this role, you will utilize your engineering expertise to support the development, design, and manufacturing of groundbreaking medical devices.

Responsibilities

• Supporting Product Development: Collaborate on risk analysis, verification, and validation testing for new products.
• Applying Engineering Tools: Utilize statistical techniques such as Gage R&R, Cpk, ANOVA, and DOE.
• Problem Solving: Implement tools such as cause-and-effect diagrams, FMEA, root-cause analysis, 5-Why, and 8D to address issues.
• Reviewing and Approving: Grant approval for engineering changes, review technical drawings, and ensure compliance with Geometric Dimensioning and Tolerancing standards.
• Maintaining Records: Ensure accuracy, thoroughness, and compliance of quality records.
• Conducting Audits: Perform internal and supplier audits to guarantee adherence to standards.
• Ensuring Compliance: Support incoming inspections, quality plans, work instructions, and regulatory requirements.
• Driving Improvement: Lead and participate in continuous improvement projects.
• Monitoring Processes: Supervise environmental and sterilization processes to maintain quality.
• Supporting Customer Needs: Investigate customer complaints and implement necessary corrective actions.
• Traveling: Occasionally visit suppliers as required.

Requirements

• A minimum of a bachelor's degree in mechanical or biomedical engineering (or equivalent experience).
• At least 5 years of engineering experience in the medical device industry (mandatory).
• Familiarity with FDA 21 CFR 820 and ISO 13485 standards.
• Experience with aseptic production or sterilization (preferred).
• Excellent written and verbal communication skills.
• Attentiveness to detail, accuracy, and thoroughness in documentation.
• Certification as a Quality Engineer (CQE) or Quality Auditor (CQA) is a plus but not required.
• Knowledge of Lean and Six Sigma practices is beneficial.