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 sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.
Manage team with activities that focus on implementing and optimizing quality engineering practices while ensuring a culture of quality and compliance with global regulatory requirements.
How you'll make an impact:
- Manage and/or lead a small team within assigned function. Develop team members to increase business acumen and functional skills
- Work on complex issues where analysis of issues requires in-depth knowledge
- Plan and direct assigned operational and project activities with the accountability for successful completion of assigned deliverables
- Identify opportunities and lead the implementation of changes to drive improvements
- Oversee engineering tasks; provide technical guidance and feedback to technicians/engineers; Guide lower level employees on more complex procedures
- Create/update complex engineering documents including requirement specs, and risk documents with robust knowledge on design control requirements
- Collaborate with cross-functional teams to lead the implementation of CAPA program including training, approvals, and system effectiveness
What you'll need (Required):
Bachelor's Degree in a related field and relevant engineering experience.
Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry.
Experience working in a regulated industry.
Demonstrated leadership experience in engineering or quality functions, including direct people management, technical leadership, mentoring, project leadership, or functional oversight of engineering teams.
Experience in senior-level engineering roles with significant leadership responsibilities, including Senior Engineer, Lead Engineer, or equivalent positions, with a minimum of 2 years of experience in such roles.
What else we look for (Preferred):
- Ability to manage technical and/or engineering disciplines and demonstrated informal mentoring and/or peer leadership skills
- Proven successful project management skills
- Proven expertise in both Microsoft Office Suite and related systems
- Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
- Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
- Extensive understanding of engineering procedures while defining team operating standards
- Extensive understanding of related aspects of quality engineering processes and/or systems
- Extensive knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards)
- Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing
- Basic financial acumen as it relates to quality engineering
- Demonstrated skill set to manage small team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
- Ability to influence cross-functional partners
- Ability to integrate metrics into the projects and operations
- 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
- Primarily interacts with internal subordinates and other supervisors
- Typically interacts with external suppliers, vendors and/or customers
- Share information and provides basic problem solving solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules
- Dedicated to quality client service and pro-active and responsive to client needs.
- Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
- Adhere to all company rules and requirements (e.g., pandemic protocols, 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
