Senior Product Safety Specialist

2 weeks ago

Galway, Galway, Ireland beBeeQualityAssurance Full time €90,000 - €120,000
Design Quality Assurance Engineer II

We are seeking a skilled professional to join our team as a Design Quality Assurance Engineer II.

Job Description:

The successful candidate will work with high-performance cross-functional development teams to ensure safety, quality, and compliance of launched products while continuously improving their commercial value. This role involves providing quality engineering support as part of new product development teams, developing and maintaining quality-engineering methodologies, systems, and practices that meet regulatory requirements.

Key Responsibilities:
  • Working knowledge of Design Controls.
  • Providing quality and compliance input to project teams for project decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
  • Creation and review of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA).
  • Understanding and supporting linkage of field data and Risk Management.
  • Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem-solving methodologies).
  • Providing quality guidance to assure country-specific compliance.
  • Championing compliance to company policies, work instructions, and SOPs.
  • Being fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
  • Supporting effective quality assurance, process controls, and metrics using data and statistical analysis to drive improvements and actions for manufacturing and assembly of products.
  • Providing quality and compliance input for post-market product sustaining activities, such as design changes, supplier auditing, and surveillance.
Required Skills and Qualifications:

A bachelor's degree in Mechanical, Electrical, Biomedical Engineering, or related fields is required, along with 2+ years of experience in Medical Device engineering. The ideal candidate will have a detailed understanding of US and International regulations, including 21 CFR part 820, and a working knowledge of IEC 60601 and EN ISO 13485.

Benefits:

Our team provides access to the latest tools, information, and training to help advance careers and skills.

Others:

The ideal candidate will be a collaborative team player who can effectively communicate with cross-functional stakeholders, prioritize tasks, and manage multiple projects simultaneously.

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