Sr. Analyst, Quality Systems

Edwards Lifesciences Gruppe; United States; On-site; USD 92,000 - 130,000; Full time

Job summary

Edwards Lifesciences is seeking a Senior Quality System Analyst to review, analyze, and evaluate business needs across units to enable quality-driven solutions. You will partner with subject matter experts, process owners and leaders, document requirements, drive process development, and interact with senior management to standardize practices.

California base pay range is $92,000 - $130,000 (highly experienced). Pay depends on qualifications and prior experience.

Qualifications

• Bachelor's degree in a related field plus 5 years' quality/manufacturing experience in medical devices.
• Ability to capture business requirements and drive process development across units.
• Strong communication and stakeholder management skills in a regulated environment.

Responsibilities

• Review, analyze, and evaluate business needs to create quality-focused solutions.
• Partner with subject matter experts, process owners, and leaders to document requirements and drive improvements.
• Interact with senior management to escalate issues and promote standardization across the organization.

Skills

MS Office Suite

Project management

Written communication

Problem solving

Quality systems knowledge

Education

Bachelor's degree

Tools

Regulatory compliance tools

Job description

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.

How you will make an impact:

• 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 escalating 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 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.
• Other incidental duties assigned by Leadership

What you'll need (Required):

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

What else we look for (Preferred):

• 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
• 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

Aligning our 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.

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).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.