Sr Manager, Quality, Program Management

Job Description

Key Responsibility:
1. Manage strategic to enterprise-wide programs and/or portfolio:
. Facilitate the creation and approval of complex business cases within the program, and coordinate the sharing of resources among projects.
. Establish, maintain, and influence program stakeholder relationships, expectations, and communications, both internal and external to the organization.
. Develop a high-level integrated milestone plan for the program and manage program changes in accordance with the change management plan to control scope, quality, schedule and cost.
. Execute program plans (quality, risk, communication, staffing, etc.) and capture and communicate program status and data to maintain accurate and current program information for the use of stakeholders.
. Serve as a subject matter expert in project and program management, including guiding and mentoring project managers sourcing and directing resources tied to projects within the program and develop expertise in a business process, professional discipline, product partnership with Corporate QA/BUQA/other stakeholders.
. Following Corporate practices and programs, actively lead region-wide Lean/Six Sigma and workshops and serve as a Business Excellence subject matter expert for APAC QA.
. Own one or more Projects on continuous improvement activities.
2. Act as SME expert in APAC for QMS subsystems and be the change management lead in EW global forum as follows:
. Review Changes with country QA for applicability/challenges.
. Review the suitability and implementation in APAC.
3. Act as audit program owner:
. Initiate, Maintain, manage APAC Audit schedule.
. Act as SME on audit process.
. Prepare Auditor talent pool for APAC.
4. Other incidental duties.
Education and Experience:
. Bachelor’s Degree in Science with 14 years experience hands on experience managing projects and/or programs & expertise QMS(ISO13485) knowledge
. Master’s Degree or equivalent in Project Management with 12 years experience hands on experience managing projects and/or programs & expertise QMS(ISO13485) knowledge.

Additional Skills:
. Proven expertise in ISO13485 and project management systems.
. Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
. Expert understanding and knowledge of principles, theories, and concepts relevant to managing multiple projects and charting the course of overall programs (portfolio).
. Strong investigation, problem-solving, organizational, analytical and critical thinking skills.
. Understanding of Quality processes of Medical Device organization.
. Experience writing and executing protocols for validation of tools, fixtures, equipment, and process.
. Knowledge and adherence to applicable regulatory requirements in APAC.
. Strict attention to detail.
. Ability to work and excel within a fast paced, dynamic, and constantly changing work environment.

. Communications ability in English for presentations, written documents, and verbal. The ability to communicate to senior management, peer levels, and subordinate levels of the organization in a clear, concise, and accurate manner.
. Green belt certification(preferred).