Fuelled by innovation, our client is dedicated to transforming lives through medical solutions that improve the health of patients around the world. We are looking for a Senior Design Quality Assurance Manager to work in their rapidly growing Structural Heart Franchise.
In this role, you will provide design assurance leadership and strategic direction by partnering with their global Structural Heart Valve 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 ensrues 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 LRP objectives.
- Is familiar with the internal auditing process.
- To establish and support a work environment of continuous improvement that supports our client's Quality Policy, Quality System and the appropriate regulations for the area.
- Ensure employees are trained to do their work and their training is documented.
What we’re looking for:
- 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 a confidential discussion on the role and the company please contact Christopher O Toole