Due to the expansion of operations our client a Major Multinational here in Galway we are seeking applications from a suitably qualified and experienced Design Assurance Senior Manager.
As the new Design Assurance Senior Manager you will join a rapidly growing Interventional Cardiology - Coronary Therapies Franchise. You will provide design assurance leadership and strategic direction in this role by partnering with global Coronary Therapies Valve R&D, Regulatory, Quality, Post Market, and Marketing teams.
- Lead the Design Assurance for New Product Introduction, Sustaining Engineering for commercialized products, and Post Market Surveillance activities
- Be the SME and lead in the areas of QSR and ISO/MDD standards, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Design Assurance Director as the final arbitrator on critical quality decisions.
- Ensure effective implementation of Risk Management deliverables to achieve compliance with ISO 14971 and demonstrate a primary commitment to patient safety.
- Lead project teams and franchises in the execution of Quality Deliverables, including but not limited to Post-Market Surveillance Plan & Report, Field Assessment Plan and Clinical Evaluation Reports
- Make decisions related to product quality, including the disposition of the non-conforming products.
- Develop and manage a high-performance design quality assurance team focusing on customer needs, compliance, product quality, and risk mitigation.
- Drive continuous improvement by championing and fostering the execution of projects within the local and Global Design Assurance and Post Market organizations to drive the process and product performance.
- Participate with and present to appropriate Corporate Quality teams.
- Develop, direct, and ensure appropriate execution of design planning, verification, validation, and usability requirements for newly designed or modified products and processes.
- Take a leadership role in developing and implementing new techniques and initiatives to enhance the Quality management system on-site and across the Corporation where possible.
- Develop staff on new quality initiatives and assist in understanding and rolling out quality initiatives across the department/site.
- To establish and support a work environment of continuous improvement that supports company Quality Policy, Quality System, and the appropriate regulations for the area.
- Ensure employees are trained to do their work, and their training is documented.
- Bachelor's Degree in Mechanical Engineering, Materials Science, Biomedical Engineering or other relevant technical disciplines.
- 8-10 years of related work experience.
- Proven technical leadership and project management skills in medical device design, development, and commercial launch.
- Proven experience in a leadership position as an Independent critical thinker, strong communicator, and networker.
- Ability to interface with customers to gather insight and get organizational buy-in on key design inputs.
- Knowledge/Experience of Design Controls and FDA/ISO Medical Device Regulations.
- Understanding of risk management and design controls tools and requirements for medical device product development.
- An influential team member, fully motivated to achieve and demonstrate best practices in line with the department and long-range planning objectives.
- Familiar with the internal auditing process.
For more information on this role and a confidential discussion please contact Michelle Mc Inerney on 091 706 717 or email firstname.lastname@example.org.