Design Quality Assurance Engineer

JWR Employment Specialists are recruiting a Design Quality Assurance Engineer for a Medical Device manufacturing company located in Galway.

The person in this role will be responsible for assuring product quality safety and effectiveness while working in a dynamic and collaborative environment.

The role will offer an attractive salary and benefits.

Duties include;

Lead Quality Engineer on projects directly contributing and/or providing guidance to others to establish appropriate Design History File / Device Master Record documentation. Providing detailed planning for clinical pilot production and scaleup plans in New Product Introduction programs

Ensuring project teams are utilizing Quality Systems and appropriate regulations and industry standards throughout the product development process

Investigating and evaluating material biocompatibility and appropriate methods of sterilization during the product design cycle

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 twoway 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 companys Quality Manual

Continually looking for improvement and compliance improvement opportunities

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

Conducting and/or participating in meetings directly with clients

Coordinating activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines. May include supplier qualification and management

Requirements

Minimum Bachelors degree in Engineering or related field

3 years of medical device design and development/quality assurance experience is required

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 and operator training is desired

Familiarity with process validation is required

Familiarity with FDA QSRs medical device regulations and ISO 13485

Familiarity with Metrology and ISO 17025 requirements

Knowledge of probability and statistics

Organised and able to selfmanage project tasks

Customer focus with excellent communication skills written and oral

Depth of knowledge in one or more clinical areas

Depth of knowledge in one or more specialized areas e.g. Biocompatibility sterilization methods etc

Experience using an electronic quality management system (eQMS) a plus

Lean or Six Sigma certification/experience preferred

Auditor experience preferred (i.e. Supplier Customer Third Party Quality Management System (QMS))

Flexibility persistence resourcefulness a drive to succeed and an entrepreneurial spirit