Design Assurance Engineer
Contract Role
Galway
Hybrid
Job Purpose
Fulfil the quality assurance responsibilities of BSC's new product development and post market, within our sustaining engineering team (i.e. commercial product support), including:
Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality in BSC.
Understanding and complying to BSC's quality, business, health & safety systems and market/legal regulations governing the quality systems.
Removing or mitigating against risks associated with the design, use and manufacture of BSC devices.
Ensuring commitment to training requirements and understanding and complying with all regulations governing their work.
Key Responsibilities
General
Completes work assignments under limited supervision/guidance.
Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.
Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
Identifies and resolves complex exceptions to work assignments.
Seeks to support improvements in product and process quality.
Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
Excellent interpersonal and communication skills with good leadership abilities.
Technical
Provides both quality and technical input to post market commercial product activities.
Experienced in post market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements).
Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
Excellent analytical and problem-solving abilities.
Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.
Leadership
Is an active team member completing quality deliverables associated with BSC's sustaining engineering and post market support.
Uses opportunities in project assignments to develop self & others.
Is a fully motivated team member - achieves and demonstrates best practices in line with set objectives.
Is willing to implement changes within the project/department practices and supports a culture of challenging the status quo to create best in class.
Qualifications & Experience
HETAC Level credits) in a STEM discipline with a minimum of 3-4 years' experience in a similar role.
Good technical capabilities, communication skills, teamwork abilities and initiative.
Proven ability to work well as part of a team & on own with minimum supervision.