Associate Documentation Specialist

Imagine how your ideas and expertise can change a patient’s life.  Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety.  You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle.  Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

Edwards Lifesciences has an opportunity for an Associate Documentation Specialist on the Transcatheter Mitral and Tricuspid Therapies (TMTT) team. This cross-functional position will have a primary focus on supporting internal customers in the processing, improvement, maintenance, and management of changes, part and drawing releases. The Associate Documentation Specialist will apply knowledge of quality and change control principals to ensure compliance with regulatory requirements and Edwards’ systems/procedures to optimize product development.

How you will make an impact: 

• Review change package against governing procedures containing DMR and Non-DMR product updates, Quality System updates, and administrative changes; interact with departments to complete the change package, and release final change package.
• Perform proofreading of manufacturing process sheet changes and incorporation of approved changes to documentation (e.g. JDE data entry and verify correct implementation).
• Participate in special projects, quality improvement initiatives, and complete assigned tasks and deliverables.
• Evaluate changes proposed by initiators and provide feedback.
• Other incidental duties assigned by Leadership.

What you'll need (Required):
Bachelor's Degree in a related field, 1 year related experience 
Associate's Degree or equivalent in related field, 3 years' related experience 

What else we look for (Preferred):
• Experience working in a medical device, healthcare, manufacturing or a regulated environment preferred (ISO 13485/MDSAP)
• Familiarity with Engineering documentation including Part Process Sheets, Engineering Drawings, Validation documents a plus
• Good computer skills in usage of MS Office Suite
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Experience with project management and project management software tools preferred
• Good knowledge and understanding of Edwards policies, procedures, and regulatory (e.g., medical, pharmaceutical) guidelines relevant to documentation
• Good understanding of medical device documentation development activities
• Full knowledge of Good Documentation Practices (GDP)
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Adhere to compliance with internal procedures
• Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness
• 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

This is a hybrid position which will require being on-site in Irvine at least 1x/week. 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 $54,000 to $77,000 (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.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinat