Job Description

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and R&D teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes process improvement, problem solving, strategic project support, people development, or any of our other product manufacturing opportunity, you will be making a meaningful contribution to our team and to patients all over the world.

Manages the team to ensure smooth and continuous operations of site quality system, quality control and assurance inspection for in process and finished goods. Oversee process audits and final product release documentation. Advise and facilitate failure investigations, compliance methodologies for manufacturing of bioprosthetic heart valves and rings.

How you'll make an impact:

• Manage supervisors and/or oversee the work of assigned quality assurance team. Develop a robust talent development plan in alignment with functional growth strategies of the department.
• Manage quality assurance project activities (e.g., CAPA) with the accountability for successful completion of all deliverables within established schedule, scope and quality objectives. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional groups
• Collaborate with cross-functional groups to manage inspection of in-process and finished goods, assemblies and components including proper implementation
• Negotiate solutions with cross-functional groups (e.g., Manufacturing Operations, Supply Chain, and Engineering) for continuous improvement
• Identify opportunities and lead the implementation of changes to drive improvements

What you'll need (Required):

• Bachelor's Degree in related field
• Experience in inspections/audits by external regulatory agencies for class II/III medical devices
• Demonstrated track record in people management
• At least 5 years experience working in medical device industry
• Demonstrated experience in decision making in a fast pace, evolving organization, with a patients first mindset

What else we look for (Preferred):

• Excellent documentation and communication skills
• Experience in working with cross functional teams and corporate stakeholders to drive achievement of objectives
• Knnowledge of financial acumen as it relates to quality
• Expert knowledge of applicable quality regulations
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality to the business
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Knowledge of Lean Manufacturing concepts and Six Sigma
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
• Develop relationships and leverage them to influence change
• Support and solicit input from team members at all levels within the organization
• Adhere to all company rules and requirements (e.g., Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control