Engineer II, Design Quality

Jobtailor; Southington (CT); On-site; USD 90,000 - 110,000; Full time

Job summary

Jobtailor is seeking a Quality Engineer to support ICU Medical Consumable development, CAPA investigations, and design controls. You will ensure compliance with regulatory requirements and participate in cross-functional teams to drive robust quality systems.

The role requires knowledge of ISO 13485, MDSAP, EU MDR, ISO 14971, and statistics, with an emphasis on CAPA, design controls, and documentation. Some travel may be required.

Qualifications

• Must be at least 18 years of age.
• Bachelor's degree in engineering or related field from an accredited college or university is required.
• Minimum of two years of experience in R&D and/or Quality is required.
• Knowledge of Quality Management Systems and linking risk management to Quality System elements.
• Knowledge of medical device standards including ISO 13485, MDSAP, EU MDR, and ISO 14971.
• Knowledge of statistics including tolerance limits and CpK.
• ASQ CQE certification is preferred.
• Knowledge of design controls, CAPA, complaints, and document control.
• Ability to support FDA and international regulatory compliance.
• Ability to travel less than 5-10% of the time.

Responsibilities

• Provide quality support for ICU Medical Consumable development.
• Support CAPA investigations and design projects.
• Ensure compliance with ICU Medical quality system requirements and applicable regulations.
• Utilize product and process controls, risk analysis/management tools, validation, design verification, investigations, and CAPA data to assure product quality.
• Assure conformance with FDA and other international regulatory agency regulations.
• Support development, application, and maintenance of quality standards.
• Ensure quality attributes for design changes are met.
• Participate in design reviews, test readiness reviews, cross-functional teams, risk assessments, and design transfers.
• Evaluate, prioritize, and mitigate potential product and process risks.
• Support internal and external audits and inspections.
• Maintain Design History Files up to date.
• Interact with cross-functional team members.
• Provide quality support for on-market product issues, bring issues to closure, and elevate to management as necessary.
• Work on special projects as assigned.

Skills

Quality Management Systems

CAPA Processes

ISO 13485

FDA Compliance

Statistical Analysis

Design Controls

Minitab

Risk Management

Document Control

Education

Bachelor's degree in engineering (Electrical, Mechanical, Biomedical)

Tools

Minitab

Job description

• Provide quality support for ICU Medical Consumable development
• Support CAPA investigations and design projects
• Ensure compliance with ICU Medical quality system requirements and applicable regulations and standards
• Utilize product and process controls, risk analysis/management tools, validation, design verification, investigations, and CAPA data to assure product quality
• Assure conformance with FDA and other international regulatory agency regulations
• Support development, application, and maintenance of quality standards
• Ensure quality attributes for design changes are met
• Participate in design reviews, test readiness reviews, cross-functional teams, risk assessments, and design transfers
• Evaluate, prioritize, and mitigate potential product and process risks
• Support internal and external audits and inspections
• Maintain Design History Files up to date
• Interact with cross-functional team members
• Provide quality support for on-market product issues, bring issues to closure, and elevate to management as necessary
• Work on special projects as assigned

Requirements

• Must be at least 18 years of age
• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university is required
• Minimum of two years of experience in R&D and/or Quality is required
• Knowledge of Quality Management Systems and linking risk management to Quality System elements
• Knowledge of medical device standards, including ISO 13485, MDSAP, EU MDR, and ISO 14971
• Knowledge of statistics, including tolerance limits and Cpk
• Minitab knowledge is preferred
• ASQ CQE certification is preferred
• Knowledge of design controls, CAPA, complaints, and document control
• Ability to support FDA and international regulatory compliance
• Ability to travel less than 5-10% of the time

Core Competencies

Demonstrates expertise in Quality Management Systems, regulatory compliance, and risk management for medical device development. Proficient in CAPA processes, design controls, and statistical analysis to ensure product quality and compliance with industry standards.

Highest-signal resume keywords

• Quality Management Systems
• CAPA Processes
• ISO 13485
• FDA Compliance
• Statistical Analysis

ATS Optimization Keywords

Hard Skills

• Risk Management
• Design Controls
• Document Control
• Quality Assurance
• Design Verification
• Validation
• Minitab
• Statistics
• Product Quality
• Process Controls

Soft Skills

• Cross-Functional Collaboration
• Problem Solving
• Communication

Certifications & Qualifications

• ASQ CQE

Industry Keywords

• Medical Device Standards
• ISO 14971
• MDSAP
• EU MDR
• Design History Files