Our client a high-paced start-up moving from Phase 2 to Phase 4 within the next 18 months working are looking to hire a Senior Quality / Design Assurance Engineer.
As a Senior Quality / Design Assurance Engineer you will get the opportunity to apply your engineering knowledge in areas such as quality systems, supplier controls, design assurance, test method development and validation, design controls, and regulatory affairs during this exciting time as they bring their product to market.
Development and application of the quality system as it relates to specified elements of the QMS, including training for compliance with ISO 13485 and the FDA Quality System Regulation (QSR).
Responsible for the development, implementation, and ongoing maintenance of Quality Management Programs aimed at optimizing product quality and processes in the sub-contract manufacturing operations and sub-tier suppliers, including supplier visits as required.
Support the implementation and oversight of Supplier Management Plans/Agreements with suppliers, including supplier review, supplier audits, issue resolution, and scorecard-based supplier performance management.
Development, issuance, and implementation of QA documentation.
Establish and maintain appropriate procedures to ensure compliance with regulatory requirements.
Review/analyze whether current products and processes (including actions or decisions conducted) comply with standards such as the QSRs, ISO 13485, EU MDR, etc.
Partners with R&D and other cross-functional partners to ensure the proper application of design controls, risk management, and the investigation/correction of design failures/challenges.
Preparation of Standard Checklists for all the applicable regulatory standards.
Performs Design Assurance activities including technical reviews of design documentation and labeling, attends design reviews, coordinates and facilitates completion and update of design risk management documentation and acts as independent reviewer for all design activities including design changes.
Technical reviews of Process Validation deliverables including IQ, OQ, and PQ as well as input to computer system validation (CSV), where required.
Assist when requested with the preparation of 510 (K) regulatory filings and subsequent FDA correspondences on supporting submissions.
Maintain detailed awareness and understanding of current regulations and regulatory guidance in regions of interest to development programs.
A level 8 Degree in an Engineering or related discipline is required.
A minimum of 5 years working experience in a quality role, preferably experience as a Quality Systems or Supplier Quality Engineer or a similar role in a medical device company.
Experience working in both an FDA and European regulatory environment is a pre-requisite.
Experience with medical device regulations including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations), and ISO quality requirements, is required.
Experience working under medical device design controls, with proven knowledge of design verification/validation and design/process FMEAs.
Strong initiative and follow through in executing responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience is required.
Excellent problem-solving, decision-making, and root cause analysis skills are desired (DMAIC).
Knowledge and demonstrated practice of risk management methodologies as per ISO 14971.
Experience in Ethylene Oxide sterilization, biocompatibility, and transportation testing is an advantage.
Proficiency with MS Office suite is required.
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.
091 706 717