Senior Quality Manager page is loaded## Senior Quality Managerlocations: Cork, Irelandtime type: Full timeposted on: Posted Todayjob requisition id: R Work Flexibility: Onsite**We're seeking a Senior Manager, Quality – Product Transfer to lead a high-performing team at the forefront of innovation in medical device manufacturing.
**In this hands-on leadership role, you'll play a pivotal part in our Product Transfer Quality team—mentoring engineers, guiding cross-functional collaboration, and ensuring every product transfer meets the highest standards of quality, safety, and regulatory compliance.
Your work will directly shape the future of life-changing medical technologies**What You Will Do:*** Sets direction: Drives the execution of Product Transfer strategy, with the goal of developing highly capable processes, that result in high yield and enable scalability.
* Builds organizational capability: Promotes the optimization of inspection strategies for launch through technology, automation, and supplier certification.
Enables the development of lean inspection strategies, enabling lower inspection cost per unit.
* Inspires others: Coaching and development of staff who champion quality assurance during the product transfer process, ensuring product transfers meet or exceed established metrics.
* Delivers results: Oversight and responsibility to ensure appropriate production and process controls are identified, qualified, and implemented throughout the manufacturing process.
* Fosters collaborative internal/external professional relationships across Divisions and functions, associated with Product Transfer.
* Collaborate with Regional QA Leaders to share and harmonize best practices, leverage lessons learned, and drive partnership and consistency within the global QA team.
* Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful Product Transfers that meet the project goals as well as the regulatory requirements.
·* Oversight and responsibility to ensure adherence to product quality performance indicators (supplier DPM, right first time, manufacturing loss, manufacturing complaints per million, units recalled, product escapes and use-as-is), in conjunction with other targets.
Continuously monitors to assess opportunities for improvement.
* Guides the team to onboard suppliers with demonstrated quality, process capability and validation.
Ensures robust supplier pFMEA, PPAP, supplier certification and inspection methods where appropriate.
* Influences processes towards validation versus manual verification, where possible.
· Drives competency in metrology within the quality assurance team including interpretation of complex engineering drawings and understanding of geometrical dimensioning and tolerance.
* Ensures compliance to Stryker Corporate, GQO and external regulatory requirements.
* Drive process development, optimization, and validation in a regulated medical device environment* Lead continuous improvement efforts and share best practices across global teams**What You Need:*** Bachelor's Degree in Engineering, Science discipline or equivalent.
Business Management or MBA is an advantage.
* Minimum of 10+ years' experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment.
* Minimum of 6+ years' experience and a proven track record of successfully creating and managing a highly talented, engaged and performing team.
* Experience in multiple areas / sites/ positions in the quality organization is advantageous.
* Expert working knowledge of regulatory requirements, standards, and regulations, with experience of managing inspections/audits by the FDA and other bodies.
* Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools.
* Demonstrated leadership ability to develop and implement organization and functional strategy.
* Initiates, sponsors, and implements change with a demonstrated track record.
* Must be able to work in a team & individual environment, influencing effectively at all levels, and across all functions with ability to develop organizational relationship and build trust.
* Demonstrated ability to make timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions.
Works with a sense of urgency always.
* The candidate must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines.Travel Percentage: 20%
#J-18808-Ljbffr