Posted: 15h ago
The role
Job Description
You will be fulfilling the QA responsibilities for new product development and post market (commercial product) support, including:
Improving patient safety, customer satisfaction and product quality.
Understanding and complying to 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 medical devices.
Ensuring commitment to training requirements and understanding and complying with all required regulations.
Key Responsibilities
Interface 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.
Represent the function for area of responsibility in both Internal and regulated Authority Audits.
Understanding of Design Assurance requirements to ensure new product/technology transfers comply to all internal and regulatory requirements.
Identify and resolve complex exceptions to work assignments.
Seek to support improvements in product and process quality.
Provides both quality and technical input to ongoing product development and post market commercial product activities.
Key Requirements
HETAC Level 8 (240 credits) in a STEM discipline with a minimum of 2-4 years' experience in a similar role.
Experienced in risk management, design and process change, standards compliance (to regulatory requirements).
Practical knowledge of ISO 13485 and FDA part 820.
Good technical capabilities, communication skills, teamwork abilities and initiative.
Proven ability to work well as part of a team & on own with minimum supervision.
Benefits
Competitive and attractive employee compensation package.
Pension contributions.
Health insurance.
Paid holidays.
Location
Galway | Ireland
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