Design Quality Assurance Engineer

Quasar Medical | Medical Device Manufacturer; Galway; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Quasar Medical, a medical device manufacturer, is seeking a Design Quality Assurance Engineer to provide quality leadership across the product development lifecycle. You will ensure regulatory compliance, lead design controls, risk management, and continuous improvement to bring safe devices to market.

The role involves CAPA, change control, supplier engagement, audits, and collaboration with cross-functional teams, in an on-site cleanroom environment in County Galway, Ireland.

Qualifications

• Bachelor's degree in Engineering or related field.
• 3 years of medical device design and development/quality assurance experience.
• Familiarity with FDA QSRs, medical device regulations and ISO 13485.

Responsabilités

• Lead Quality Engineer on projects, providing guidance to establish quality documentation and pilot production/scale-up plans.
• Ensure project teams use Quasar Medical Quality Systems and comply with regulations and standards.
• Conduct design risk assessments to verify function and safety.
• Own CAPA, change control, audits, product release, document control, DHF and device master records.
• Engage with customers and suppliers; audit and qualify new suppliers as needed; communicate proactively.
• Contribute to resolution of technical issues and drive continuous improvement.
• Ensure all work satisfies the Quality Management System requirements.
• Lead quality roles on client programs, and assist in designing/methodologies, materials, processes or products; document accordingly.
• Maintain comprehensive documentation across all R&D phases, including user needs, product requirements and risk/test planning.

Connaissances

Quality leadership

Regulatory compliance

CAPA management

Risk assessment

Documentation

Formation

Bachelor's degree in Engineering

Outils

eQMS

FDA QSRs

ISO 13485

Description du poste

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.
• 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.

Working Conditions and Physical Demands

While performing the duties of this job, the employee is regularly required to look at a computer screen, reports and other documents. The employee is regularly required to use their hands on a computer keyboard or a calculator. The employee is regularly required to sit, talk, hear and interact with other employees. The employee is regularly required to stand and walk.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

On-site role in a cleanroom and controlled manufacturing environment.

Equal Opportunity Statement

Quasar Medical provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.