A Design Quality Engineer is a professional who plays a critical role in ensuring the quality and reliability of design processes and products. They are responsible for implementing quality standards, identifying and resolving design issues, and ensuring compliance with regulations and industry standards. In this blog post, we will describe the primary responsibilities and the most in-demand hard and soft skills for Design Quality Engineers.

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Main Responsibilities of a Design Quality Engineer

The following list describes the typical responsibilities of a Design Quality Engineer:

Analyze

Analyze preliminary plans and develop reliability.

Apply

Apply knowledge of Design Control principles and quality.

Carry out

Carry out internal audits when required.

Champion

Champion continuous improvement initiatives within the design department.

Collaborate with

• Collaborate with cross-functional teams to ensure design compliance.

• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.

• Collaborate with external stakeholders, such as customers and regulatory agencies.

• Collaborate with suppliers to ensure the quality of purchased components.

Collect

Collect, analyze and interpret statistical data.

Complete

Complete Document Change Request Reviews in a timely and objective manner.

Conduct

• Conduct audits and inspections of design processes and procedures.

• Conduct quality assurance tests.

• Conduct quality-related software activities to deliver consistent.

• Conduct risk assessments and identify potential design flaws.

• Conduct root cause analysis and implement corrective actions for design issues.

• Conduct usability studies and incorporate user feedback into design improvements.

Contribute

• Contribute to defining and timely achievement of overall project goals.

Coordinate with

• Coordinate quality decisions between different quality and engineering groups.

• Coordinate with design groups on quality systems.

• Coordinate with manufacturing teams to ensure smooth transition from design to production.

Design

• Design and conduct experiments for process optimization and / or improvement.

• Design and validate test methods for evaluating product reliability.

• Design plans and risk management deliverables (e.g. FMEAs).

Develop

• Develop and implement quality control plans for design processes.

• Develop and implement risk acceptability criteria as a part of the Risk Management Process.

• Develop and lead other team members.

• Develop and maintain design control procedures and processes.

• Develop and maintain design inspection and testing procedures.

• Develop procedures for inspecting and testing of finished products.

Drive

Drive predictive engineering methodology principles (DRM).

Ensure

• Ensure compliance to external & internal requirements and actively support and engage in Design.

• Ensure compliance with relevant quality management system (QMS) standards.

• Ensure compliant documentation related to area of responsibility.

• Ensure DHF content completion, integrity, and regulatory & standards compliance.

• Ensure product development.

• Ensure product development activities.

• Ensure successful transfer of new products to manufacturing.

• Ensure that medical devices are developed.

• Ensure that quality and compliance to site procedures are communicated and implemented.

• Ensure that released devices are safe and effective and meet their intended use.

• Ensure the of deliverable Design transfer sufficiency and effectiveness.

Establish

Establish priorities of individual or project assignments.

Evaluate

Evaluate design requirements and specifications.

Facilitate

• Facilitate analysis and activities associated with corporate privacy and security procedures.

• Facilitate usability analysis and activities in accordance with IEC 62366.

Help

Help coach project teams on use of quality system.

Identify

Identify and propose remediation for existing and potential quality issues.

Implement

• Implement and maintain design risk management processes.

• Implement in-process and final inspection tooling and fixturing.

Initiate

• Initiate or maintains schedule for projects and project milestones.

• Initiate product Quality Plans.

Interact with

Interact constructively with employees.

Investigate

Investigate and analyze design-related complaints or non-conformances.

Lead

• Lead, coach, and mentor non-exempt and entry level exempt personnel.

• Lead Interior and Exterior Harmony Review with cross functional team for the appearance approval.

• Lead on-time completion of Design Control Deliverables.

• Lead process control and monitoring of CTQ parameters and specifications.

• Lead quality related problem solving for software.

• Lead Risk Management activities from product Concept through Commercialization.

• Lead the investigation, resolution and prevention of product and process nonconformances.

Liaise with

Liaise with project and program team members on technical and quality matters.

Maintain

• Maintain a thorough understanding of relevant design and quality engineering principles.

• Maintain complete and compliant Design History Files in the eQMS.

Make

Make a substantial contribution to ways of combining Agile with medical software development.

Manage

• Manage complaint system, tracking timely investigation and closure of complaints.

• Manage post-release safety risks associated with complaints and returns.

Mentor

Mentor less senior Quality Engineers and technicians.

Monitor

• Monitor and analyze design metrics to identify improvement opportunities.

• Monitor and track design changes and ensure proper documentation.

Oversee

• Oversee Preventive Maintenance and Calibration activities.

• Oversee quality and risk management throughout the software lifecycle.

Own

• Own quality training process.

• Own tool validation process.

Participate in

• Participate in Defect / Issue Management and Change Control Boards, as appropriate.

• Participate in design failure mode and effects analysis (DFMEA) activities.

• Participate in design reviews and provide input on quality aspects.

• Participate in engineering Design Reviews.

• Participate in regulatory and compliance audits.

• Participate in requirement review.

• Participate in SW failure mode analysis.

• Participate in the development of requirements, software design, and software test design.

• Participate on project teams and technical review boards.

Perform

• Perform analyses and provide reports to management.

• Perform design verification and validation activities.

• Perform product failure investigations and other CAPA related activities.

• Perform risk assessments for Defect Tracking Support, Technical Review Boards & CAPAs.

• Perform statistical analysis to evaluate design performance.

• Perform tolerance analysis on mechanical and electrical assemblies.

Plan

• Plan and organize project assignments of substantial variety and complexity.

• Plan and perform assignments with a wide degree of difficulty.

• Plan and the qualification activities required to meet validation.

Prepare

• Prepare and present reports on design quality performance to management.

• Prepare for and participate in project and quality systems audits and inspections.

Produce

Produce and completes Quality Engineering documents under direct supervision.

Promote

Promote cybersecurity principles & testing in all aspects of software development.

Propose

Propose changes in design to improve system and / or process reliability.

Provide

• Provide and / or participate in Design Control training.

• Provide compliant solutions to a variety of complex problems.

• Provide compliant solutions to a variety of problems of moderate scope and complexity.

• Provide guidance on the principles of applicable standards as.

• Provide guidance to other Professionals and Technicians.

• Provide input and support throughout product's life cycle.

• Provide input into component and process quality requirements.

• Provide input on design-for-quality matters.

• Provide risk analysis leadership for all departments.

• Provide supporting information for change including reasons and justifications.

• Provide technical guidance and support to junior quality engineers.

• Provide technical leadership to business units.

• Provide training and support to design teams on quality-related topics.

Record

Record and document the appearance validation activity for parts evaluation reports.

Represent

Represent QA on product defect review boards, and change control boards.

Review

• Review and approve design documentation, including drawings and specifications.

• Review and approve verification and validation test plans.

• Review and verification of documentation and metrics) at Product Realization Process milestones.

• Review design history files and technical files for conformance to applicable requirements.

• Review new and modified product designs for quality characteristics.

• Review production validation methods.

• Review, Technical Reviews and Clinical Readiness Reviews.

• Review tooling requirements and perform IQ / OQ / PQ as necessary.

• Review, validate and maintain the color material finish (CMF) Specbook and Visible BOM List.

Select

Select methods and techniques to lead a project to completion.

Stay updated with

Stay updated with industry standards and regulatory requirements.

Support

• Support and ensure internal & external audit responses.

• Support and ensure on time product re-certifications.

• Support CAPA, SCAR and NCR investigation and administration.

• Support clean room certification and validation activities.

• Support design test and inspection method development, and lead method validation activities.

• Support maintenance and updates as necessary of the Quality Management System (QMS) procedures.

• Support, reviews and approves Document Change Orders.

• Support the implementation of new design tools and technologies.

• Support the maintenance of calibration activities and records.

• Support transit validations and product shelf life testing activities.

Take

Take part in Risk (SRA / DRA / PSRA) assessment as risk management team member.

Track

Track timelines and facilitating the required Quality Engineering deliverables.

Understand

Understand automotive paint system process such as solid and metallic 2K Coating, Baking, etc..

Utilize

Utilize problem solving methodologies.

Work with

• Work closely with our Customer Care to recover and correctly interpret insights from the field.

• Work closely with software engineers.

• Work cross functionally to help identify root cause and any necessary corrective actions.

• Work independently to determine and develop.

Write

Write / review and approve test protocols and reports, establish sampling plans.

Most In-demand Hard Skills

The following list describes the most required technical skills of a Design Quality Engineer:

1. Proficiency in CAD (Computer-Aided Design) software.

2. Knowledge of design control and risk management processes.

3. Familiarity with statistical analysis tools and techniques.

4. Understanding of regulatory requirements, such as ISO 13485 or FDA regulations.

5. Expertise in design verification and validation methodologies.

6. Strong knowledge of quality management systems (QMS).

7. Experience with failure analysis techniques.

8. Proficiency in applying statistical process control (SPC) methods.

9. Understanding of Design for Manufacturing and Assembly (DFMA) principles.

10. Knowledge of material science and engineering properties.

11. Proficiency in using quality tools, such as root cause analysis and fishbone diagrams.

12. Familiarity with reliability engineering principles.

13. Experience with design and process capability analysis.

14. Knowledge of geometric dimensioning and tolerancing (GD&T).

15. Expertise in problem-solving methodologies, such as Six Sigma or Lean.

16. Understanding of usability engineering principles.

17. Proficiency in conducting design reviews and audits.

18. Knowledge of design change management processes.

19. Experience with validation and qualification of manufacturing processes.

20. Familiarity with industry-specific design standards and best practices.

Most In-demand Soft Skills

The following list describes the most required soft skills of a Design Quality Engineer:

1. Strong analytical and problem-solving skills.

2. Excellent communication and interpersonal skills.

3. Attention to detail and a high degree of accuracy.

4. Ability to work effectively in cross-functional teams.

5. Strong organizational and time management skills.

6. Adaptability and flexibility inThe following list describes the most required soft skills of a Design Quality Engineer:

7. Strong analytical and problem-solving skills.

8. Excellent communication and interpersonal skills.

9. Attention to detail and a high degree of accuracy.

10. Ability to work effectively in cross-functional teams.

11. Strong organizational and time management skills.

12. Adaptability and flexibility in handling changing priorities and requirements.

13. Critical thinking and decision-making abilities.

14. Ability to work independently and take initiative.

15. Leadership and teamwork skills.

16. Continuous learning mindset to stay updated with evolving technologies and industry practices.

Conclusion

In conclusion, a Design Quality Engineer plays a vital role in ensuring the quality and reliability of design processes and products. They have a wide range of responsibilities, from evaluating design requirements to collaborating with cross-functional teams and resolving design issues. To succeed in this role, Design Quality Engineers need a combination of technical expertise and soft skills. Technical skills include proficiency in CAD software, knowledge of design control processes, statistical analysis, and regulatory requirements. Soft skills include strong analytical and problem-solving abilities, effective communication, and the ability to work in teams and adapt to changing situations.