Associate Specialist, Documentation

Imagine how your ideas and expertise can change a patients 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. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

How you will make an impact:

Ensure compliance with internal procedures coordinate and perform archiving and control of documentation

Assist in managing archiving daily activities including storage and retrieval of records to and from the off-site storage supplier internal document archival and retrieval process (internal & external) etc.

Ensure orderly work and proper segregation of documents including storage and identification

Report coordinate and follow up on Annual Document Review of local site SOPs

Scan verify and upload documents into Product Data Management System i.e. APEX ARAS Ignite etc. for completed WO validation reports TR/TP

Assist in managing legacy document stored in electronic media as well as ESS and maintain the corresponding inventory list

Conduct backroom (e.g. documentation preparation room) activities to support external audits and ensure timely response to documentation requests for auditors

Participate/lead in projects (e.g. documentation remediation) in collaboration with team members; identify opportunities for process improvement

Support the investigation of non-conformities and CAPAs related to the area including root cause analysis

Other incidental duties assigned by Leadership

What youll need (Required):
Bachelors Degree in related field with 1 year of previous related experience or

Diploma in related field with 3 years of previous related experience required

What else we look for (Preferred):

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

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

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

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