Our client, a medical device company in Galway is currently looking to recruit a Senior Design Assurance Engineer for their site.
The role of Senior Design Assurance Engineer is to be the QA technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs. Assure compliance to applicable regulations and lead quality activities such as risk assessments, device testing, audits, procedure development, documentation review and changes to controlled documents. Provides design control, risk management and compliance support for product design and manufacturing, corrective and preventive actions, product/process improvements and complaint investigations.
- Responsible for compliance of product development, risk management and post market activities with Policies and Procedures and applicable International Regulations.
- Works as part of product development team in identifying and translating user requirements into design requirements, identifying critical design features and components, including contributing towards the generation of risk management documents and associated reports.
- Complete design verification, design validation and test method validation activities associated with product development and implementing design/process changes.
- Works with R&D and manufacturing engineering in translating design requirements into manufacturing requirements, including the development of manufacturing test methods and implementation of production monitoring and controls.
- Leads the resolution of project issues by working with team members, suppliers, and others as appropriate. Apply thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
- Monitors compliance with policies, procedures and applicable regulatory requirements, identifying, reporting and implementing process and system improvements.
- Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to product development, post market activities, project and team environments.
- Represent the company professionally and positively to external agencies, vendors and regulators.
- Other responsibilities will include (but are not limited to) the following:
- Leads and/or facilitates compliance and improvement activities associated with the quality system (e.g. CAPA, audit programs, personnel training).
- Actively participates in and supports departmental activities and responsibilities in accordance with existing procedures and external regulations.
- Plan, execute, report and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required.
- Makes decisions that are aligned with management objectives regarding work processes, plans and schedules in order to achieve quality objectives.
- Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans. Assists department and project leaders in developing and reporting appropriate performance and quality metrics.
- Reviews and approves operational, test and validation data to establish conformance to technical specifications and performance standards for existing, new or modified products and processes.
- Provides technical quality guidance to team members, technician and inspection staff.
- Minimum Bachelor's Degree in Engineering, Science or related technical field.
- 6 years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite. Ideally includes a minimum of 4 years in the QA activities associated with a product development including project management skills and leadership ability.
- Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016, the European Medical Device Regulations, the Canadian Medical Device Regulations and other international standards and regulations.
- Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
- Excellent interpersonal skills and ability to work with people to achieve results.
- Excellent written and communication skills, fluency in English. Proficiency in MS office products.
- Experience in preparation for notified body and FDA inspections.
- Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both the company and their customers.
- Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
- Good business acumen.
- Approachable and enthusiastic.
- Strong attention to detail
- Flexible and adaptable.
- Able to work on own initiative and as a team player.
- Good organizational skills with cultural awareness and sensitivity
- Demonstrates and actively promotes the highest levels of professional behaviour and personal integrity.
For further information on this Senior Design Assurance Engineer role in Galway please contact Bimi Felix on 086 8395533 / email@example.com
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