Our client a Major Multi National here in Galway are looking to hire a Design Assurance Manager.
In this role, you will provide design assurance leadership and strategic direction by partnering with R&D, Regulatory, Quality and Marketing teams.
- Areas of responsibility may include: Design Assurance for New Product Introduction; Sustaining Engineering for commercialized products; Post Market Surveillance activities
- Is viewed as a leader or expert in the areas of QSR and ISO/MDD standards within ones own group, 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.
- Ensures effective implementation of Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety. Leads 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
- Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
- Develops and manages a high performance design quality assurance team with focus on customer needs, compliance, product quality, and risk mitigation.
- Drives continuous improvement by championing and fostering the execution of projects within the local and/or Global Design Assurance and Post Market organizations to continue to improve process and product performance.
- May be a member of and present to appropriate Corporate Quality teams.
- Develops, directs and ensures appropriate execution of design planning, design verification, design validation and useability requirements for newly designed or modified products and processes.
- Takes 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.
- Is key to developing staff on new quality initiatives and assists understanding and rollout of quality initiatives across the department/site.
- Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the department and long range planning objectives.
- Is familiar with the internal auditing process.
- To establish and support a work environment of continuous improvement that supports the 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 Technical Degree such as Mechanical Engineering, Materials Science and/or Biomedical Engineering.
- 8-10 years of related work experience.
- Proven technical leadership and project management skills in medical device design, development and commercial launch.
- Proven key leadership traits of ability to be independent critical thinker, strong communication skills and ability to build effective cross-functional relationships
- 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.
For more information or a confidential discussion about this role please contact Michelle Mc Inerney.
091 706 717