Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
How you will 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
• Other incidental duties
What you'll need (Required):
• Bachelor's Degree in related field & experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry required
• Experience working in a regulated industry Preferred
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