This role supports all Edwards business units, regions and site through the review, analysis, and evaluation of business needs to create solutions that support overall business strategies. The Senior Quality System Analyst is responsible for effectively partnering with subject matter experts, process owners and functional leaders across the organization in helping to document business requirements, defining scope and objectives that drive process development and implementation while promoting a collaborative atmosphere of quality awareness and continuous improvement. Interact and present to senior management through the escalation process to drive for simplification and standardization across the organization. Functions as an integrator between the business users, IT and corporate compliance with both business and technical expertise.
Job Functions: - Support Corporate Quality strategic initiatives by working with business representatives to understand, and document the business requirements, processes and workflows developing both written and visual depictions of requirements and process flows.
- Partner effectively with all levels of the organization to drive results, proactively identify and resolve problems, manage conflicts and escalate as required.
- Work with IT to develop functional specifications and act as Subject Matter Expert for the proposed solutions.
- Work with the Corporate Quality PMO to ensure solutions are successfully developed, deployed and sustained in line with overall Corporate Quality objectives.
- Lead medium to large scale projects where analysis of situations requires an in-depth evaluation of multiple factors and/or requires an in-depth knowledge of organizational objectives in conjunction with Quality / Regulatory compliance requirements.
- Drive to resolve these issues completely and with speed by leveraging your network of key contacts outside your own area of expertise.
- You will suggest and drive improvement of current practices and work with the appropriate functions to implement changes or participate in their implementation.
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Qualifications Education/Experience: - Education Level: Bachelor's Degree, Field of Study: related field, plus 5 years of experience in quality and/or manufacturing environment in the medical device or pharmaceutical industry.
Required Skills: - Proven expertise in MS Office Suite.
- Good project management skills and related software tools preferred.
- Excellent written and verbal communication skills including negotiating and relationship management skills.
- Strong problem-solving and critical thinking skills.
- Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems.
- Full knowledge of medical or pharmaceutical regulations as relating to documentation.
- Full understanding of medical devices regulations (e.g., FDA (21 CFR Part 820) and ISO13485).
- Strict attention to detail producing high quality work.
- Ability to interact professionally with all organizational levels.
- Strong ability to manage and work with different cultures and nationalities, experience working in complex global environment.
- Ability to manage competing priorities in a fast paced environment, show initiative and be flexible.
- Working experience influencing others to action who are not direct reports.
- Work is performed independently on complex projects and reviewed for accuracy and soundness.
- Applies sound judgment when making decisions and communicating with peers and management.
- Ability to adapt to new technologies and rapidly changing environment.
