Functional Overview:  Reporting to the Director of Quality and Regulatory Affairs, the Quality Engineer is responsible for ensuring that products are developed and manufactured in compliance with regulatory standards and industry best practices. The Quality Engineer is accountable for managing design control, risk management and process validations while actively participating in continuous improvement efforts to enhance overall product quality.

Major Job Responsibilities, Functions, and Duties:

Design Control

• Lead design control activities, including the review of design inputs, design outputs, design verification, and design validation activities.
• Establish Finished Good Specifications including process parameters, material requirements, and in-process and final release testing.
• Review product development documentation to ensure compliance with regulatory standards.

Risk Management

• Conduct Risk Management activities, including Failure Mode and Effect Analysis (FMEA) and other risk assessment methodologies.

Process Validation

• Lead validation efforts of manufacturing processes, equipment, and systems, ensuring that product performance and process outcomes meet established requirements.
• Develop validation documentation including Master Validation Plans (MVP), Factory/Site Acceptance Testing (FAT/SAT), Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ).
• Author, review and approve test protocols, validation plans, and reports for new product introductions and changes to existing products.

Corrective and Preventive Action

• Assist in the investigation, root cause analysis, and closure of manufacturer’s Non-Conforming Material Reports (NCMR) and Corrective and Preventive Actions (CAPA).

Continuous Improvement

• Lead and participate in continuous improvement initiatives to enhance product quality and operational efficiency.

General Job Requirements:

• Bachelor’s degree in Engineering or a related field (e.g., Biomedical Engineering, Chemical Engineering, Mechanical Engineering).
• 3+ years of experience in quality assurance within the medical device, pharmaceutical, or regulated industry.
• Hands-on experience with FDA regulations (21 CFR 820), ISO 13485 and ISO 14971 standards.
• Experience with risk management, design control processes, root cause analysis and corrective actions.
• Knowledge of process validation and of statistical analysis and problem-solving techniques including DOE and SPC
• Excellent communication and interpersonal skills, with the ability to work cross-functionally in a fast-paced environment.
• Ability to read, analyze and interpret professional journals, standards, technical procedures and governmental regulations.
• Detail-oriented with strong analytical and organizational skills.
• Proficiency in Microsoft Office Suite and quality management software (e.g., Veeva Vault, etc.).

Physical Job Requirements:

• Able to work in Typenex Medical office located in Chicago, Illinois and at the Typenex Medical warehouse located in Mount Pleasant, Wisconsin.
• Able to travel both domestically and internationally.
• Able to remain in a stationary position, either sitting or standing for a prolonged period of time.
• Able to move about the office to access common equipment such as file cabinets, copiers, printers, etc.
• Able to move or lift objects up to 25 pounds

Compensation:

The salary range is $100,000 to $110,000 annually.

Benefits:

Typenex Medical is pleased to offer its full-time employees extensive and generous benefits. We offer three medical insurance plans with monthly premiums starting at only $1, as well as $1 monthly premium dental and vision plans. Our employees enjoy multiple other benefits such as a flexible time off policy, a 401(k) match, disability and life insurance, and so much more.

About Typenex Medical:

Typenex Medical is focused on creating solutions for hospitals, surgery centers and laboratories that enhance safety and efficiency, for both staff and patients. Typenex is entering new markets within healthcare and is growing the team at a fast pace. We are a small team looking to continue to make a large impact in our target markets through smart design, strong execution, and outstanding customer service.