Sr. Analyst, Quality Systems

About the role

This role supports all Edwards business units, regions, and sites 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 to document business requirements, define scope and objectives, and drive process development and implementation while promoting a collaborative atmosphere of quality awareness and continuous improvement.

You will interact and present to senior management through the escalation process to drive simplification and standardization across the organization. The role functions as an integrator between business users, IT, and corporate compliance with both business and technical expertise.

Responsibilities

• Support Corporate Quality strategic initiatives by working with business representatives to understand, document, and analyze 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 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 in-depth knowledge of organizational objectives in conjunction with Quality/Regulatory compliance requirements.
• Drive resolution of complex issues by leveraging your network of key contacts outside your own area of expertise.
• Suggest and drive improvement of current practices and work with the appropriate functions to implement changes or participate in their implementation.
• Perform other incidental duties as assigned by leadership.

Requirements

• Bachelor’s Degree in a related field.
• 5 years’ experience in a quality and/or manufacturing environment in the medical device industry or equivalent work experience based on Edwards criteria.

Preferred Qualifications

• Proven expertise in MS Office Suite.
• Good project management skills and related software tools.
• Excellent written and verbal communication skills, including negotiating and relationship management.
• 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 they relate to documentation.
• Full understanding of medical device regulations (e.g., FDA (21 CFR Part 820) and ISO 13485).
• 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 a 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.
• Ability to work independently on complex projects with reviews focused on accuracy and soundness.
• Applies sound judgment when making decisions and communicating with peers and management.
• Ability to adapt to new technologies and a rapidly changing environment.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures to prevent injuries and protect the environment.

Pay

For California, the base pay range for this position is $92,000 - $130,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Benefits

Aligning overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.