Sr Manager, Quality Assurance

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 will make an impact:
Key Responsibilities:
• Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design on new products and/or processes. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups
• Manage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department
• Provide technical guidance to cross-functional and/or departmental groups to develop and provide design recommendations that integrate into component(s) or product(s) with moderate complexity

• Provide technical guidance to cross-functional and/or departmental groups on design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing

• Other incidental duties

What you'll need (Required):
Bachelor's Degree in engineering Required and
Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry Required and
Demonstrated track record in management of technical and/or engineering disciplines Required
Experience working in a regulated industry Preferred

What else we look for (Preferred):
Additional Skills:
• Proven successful project management leadership 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
• Expert understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
• Expert understanding of related aspects of quality engineering processes and/or systems
• Expert 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
• Knowledge of financial acumen as it relates to the business as well as quality engineering
• Demonstrated ability to direct teams 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 develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality engineering to the business
• Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT
• 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
• Frequently interacts with subordinate production supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team
• Participate and present at meetings with internal and external representatives
• Resolve operational and scheduling issues
• 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.
• 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., 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 environm