Manager, Quality
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Job Location:
Monthly Salary:
Posted on:
23 hours ago
Vacancies:
1 Vacancy
Job Summary
Imagine how your ideas and expertise can change a patients 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. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products 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 skillsWork 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 youll need (Required):
Bachelors Degree in related field & experience in Quality Engineering Quality Management and/or Regulatory Compliance within the medical device industry requiredExperience 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 skillsProven 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
Required Experience:
Manager
Key Skills
- APQP
- Quality Assurance
- ISO 9001
- Lean Six Sigma
- PPAP
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Control
- Quality Management
- As9100
- Manufacturing
About Company
Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more
