Sr. Analyst, Quality Systems

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 92,000 - 130,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Senior Quality System Analyst to partner with subject matter experts and leaders to document business requirements, define scope, and drive process development and implementation while promoting quality and continuous improvement.

You will lead medium to large scale projects, coordinate with IT, Compliance and PMO to ensure solutions are deployed and sustained, and escalate to senior management to simplify and standardize processes across the

Qualifications

• Bachelor's degree in related field is required.
• 5+ years in quality and/or manufacturing in medical device industry or equivalent.
• Strong written and verbal communication skills.

Responsibilities

• Document business requirements, scopes and objectives to drive process development.
• Lead medium to large scale projects with quality/regulatory considerations.
• Partner with executives, subject matter experts, and PMO to deploy sustainable solutions.
• Promote a culture of quality awareness and continuous improvement across the org.
• Interact with senior management to escalate and simplify processes.

Skills

Quality systems

Project management

Regulatory knowledge

Cross-functional collaboration

Analytical thinking

Education

Bachelor's degree in related field

Tools

MS Office Suite

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 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 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 LeadershipWhat 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 criteriaWhat 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/controlAligning 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). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.