Design Quality Engineer

HERO Recruitment; Galway; On-site; EUR 60,000 - 75,000; Full time

Job summary

HERO Recruitment Ltd. seeks a Design Quality Assurance Engineer to support medical device development through design controls, risk management, and QA documentation across the product lifecycle.

The role ensures compliance with regulatory standards (FDA QSRs, ISO 13485) and the company’s QMS, leading CAPA, change control, supplier audits, and document control while collaborating with cross-functional teams to deliver safe and effective devices.

Qualifications

• Bachelor's degree in Engineering or related field.
• 3 years of medical device design and development/quality assurance experience.
• Experience with FDA QSRs, medical device regulations and ISO 13485.
• Proven ability to lead product verification & validation activities.
• Experience using an electronic quality management system (eQMS) is a plus.

Responsibilities

• Lead Quality Engineer on projects, guiding teams to establish quality documentation.
• Ensure project teams follow Quasar Medical Quality Systems and regulatory standards.
• Conduct risk assessments of the design to ensure intended functionality.
• Manage CAPA, change control, audits, DHF, and device master records.
• Coordinate with customers and suppliers for effective information exchange and audits.
• Contribute to error-free design history files and design controls.
• Support continuous improvement projects and methodologies across programs.

Skills

Quality leadership

Regulatory compliance

Risk management

CAPA

Design controls

Auditing

eQMS

Education

Bachelor's degree in Engineering or related field

Job description

Job Description Job Title: Design Quality Assurance Engineer

The Design Quality Assurance Engineer provides quality support and leadership throughout the product development lifecycle, ensuring compliance with regulatory requirements, industry standards, and the Quality Management System. The role supports New Product Development (NPD) programs through design controls, risk management, quality documentation, supplier engagement, and continuous improvement activities to ensure the successful development and commercialization of safe and effective medical devices.

Essential Job Duties and Responsibilities

• As a lead Quality Engineer on projects, directly contributing and/or providing guidance to others to establish quality documentation. Providing detailed planning for pilot production and scale-up plans in New Product Development programs.
• Ensuring project teams are utilizing Quasar Medical Quality Systems and appropriate regulations and industry standards throughout the product development process.
• Conducting risk assessments of the design to determine ability to function as intended.
• Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process and design history files (DHF), device master records, etc.
• Interacting with customer and supplier companies in a professional manner; proactively communicating with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.
• Intervening and contributing to successful resolution of technical issues when they arise.
• Ensuring that all work satisfies the requirements of the company's Quality Management System.
• Supporting continuous improvement projects
• Leading Quality roles on client programs, assisting in the design and implementation of new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation.
• Maintaining detailed documentation throughout all phases of research and development, often leading documentation of user needs, product requirement and risk / test planning and execution activities.
• Coordinating activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
• Provide document and quality system support during internal, customer, supplier, and regulatory audits

Education and Experience Requirements

• Minimum Bachelor's degree in Engineering or related field.
• 3 years of medical device design and development/quality assurance experience is required.

Preferred Skills and Abilities

• Managing customer relationships and responses in aa timely manner.
• Ability to interact with client companies in a professional manner.
• Demonstrated ability to lead product verification & validation activities
• Experience working with operations to develop strong manufacturing process instructions is desired.
• Familiarity with FDA QSRs, medical device regulations and ISO 13485
• Knowledge of probability and statistics.
• Organised and able to self-manage project tasks.
• Customer focus with excellent communication skills, written and oral.
• Experience using an electronic quality management system (eQMS) a plus.
• Lean or Six Sigma certification/experience.
• Auditor experience preferred (i.e. Supplier, Customer, Third Party, Quality Management System (QMS))
• Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.