Job Description:
We are seeking a highly skilled Senior Manager to lead our Quality Engineering team. As a key strategic leader, you will oversee the execution of syringe system assembly, manufacturing, product testing, and life-cycle management goals and objectives for our Integrated Systems Operating Unit.
Your primary responsibility will be to develop and implement compliant state-of-the-art QMS infrastructure to support manufacture and distribution of syringe systems and drug containment solutions. You will manage all team members in Ireland, oversee product release, including management of all third-party subcontractors and their operations, and ensure product quality is maintained.
As a cross-functional leader, you will work closely with global leaders to ensure harmonization, alignment, and best practices across the QMS and product platforms. You will also build and maintain a high-performing team, ensuring talent development and succession planning within the OU for Quality.
Key Responsibilities:
* Develop and implement comprehensive product life-cycle manufacturing and distribution strategies
* Drive stabilization of quality metrics and compliance profile of product manufacturing and post-market surveillance activities
* Manage a high-performing global team responsible for ensuring products comply with specifications and applicable global quality and regulatory requirements
* Partner with internal and external stakeholders to deploy strategic platform product manufacturing and post-market surveillance strategies
Required Skills and Qualifications:
To be successful in this role, you will need:
* Bachelor's degree in Science or an applicable engineering field or equivalent experience in engineering
* Minimum 10 years of experience in regulated Quality industry
* Minimum 5 years of managing people/staff
* Extensive experience with medical device and/or combination device product life-cycle management
Benefits:
We offer a competitive compensation package, excellent benefits, and opportunities for professional growth and development.
Others:
This role requires strong leadership and communication skills, as well as the ability to adapt to frequent changes and unexpected events. If you are a motivated and results-driven individual with a passion for quality and excellence, we encourage you to apply.
Keyword: Quality