Engineering Document Specialist II

JOB DESCRIPTION

GLAUKOS - ENGINEERING DOCMENTATION SPECIALIST II (BURLINGTON, MA)

How will you make an impact?

We are seeking a meticulous and detail-oriented Engineering Documentation Specialist to join our team. The ideal candidate will be responsible for ensuring the accuracy, completeness, and compliance of all documentation related to our processes and products.

This role requires proficiency in utilizing various software tools, including Oracle for ECO implementation, Veeva for DCC initiation, Track Wise digital, and CR creation and documentation.

The Engineering Documentation Specialist will play a crucial role in maintaining quality standards and regulatory compliance within our organization.

What will you do?

• Change Control Management : Utilize Oracle for initiation of Engineering Change Orders (ECOs), ensuring accurate documentation of changes and adherence to regulatory requirements and guidelines.
• Quality Management Systems (QMS) : Maintain and improve the QMS documentation, ensuring alignment with regulatory standards (e.g., FDA, ISO).
• Veeva DCC Initiation : Initiate and manage documents within the Veeva Document Change Control (DCC) system, Aiding engineering in the document lifecycle from creation to archival.
• Track Wise Digital : Utilize Track Wise digital platform for managing deviations, investigations, corrective and preventive actions (CAPAs), and other quality events, ensuring timely resolution and documentation.
• Change Request (CR) Creation : Generate and manage Change Requests within designated systems, facilitating cross-functional communication and documentation of change initiatives.
• Training and Compliance : Collaborate with training teams to ensure documents are appropriately linked to training requirements, facilitating compliance with regulatory and internal standards.
• Continuous Improvement : Identify opportunities for process optimization and efficiency gains within the document control processes, driving continuous improvement initiatives.
• Cross-Functional Collaboration : Work closely with stakeholders across departments (e.g., Quality Assurance, Regulatory Affairs, Manufacturing) to ensure documentation requirements are met and maintained.

How will you get here?

• Bachelor's Degree in a relevant field.
• 2-5 years relevant work experience
• Proven experience in documentation management within a regulated industry, such as pharmaceuticals, biotechnology, medical devices, or similar.
• Proficiency in using Oracle for ECO implementation and Track Wise digital for document and quality event management.
• Experience with Veeva DCC initiation and management is highly desirable.
• Strong understanding of document control principles, quality management systems, and regulatory requirements (e.g., FDA, ISO).
• Excellent attention to detail and organizational skills, with the ability to manage multiple tasks simultaneously.
• Effective communication and interpersonal skills, with the ability to collaborate cross-functionally and influence stakeholders at all levels.
• Analytical mindset with problem-solving abilities, capable of identifying process improvements and driving change initiatives.
• Familiarity with electronic document management systems (EDMS) and proficiency in MS Office Suite.
• Commitment to upholding quality standards, integrity, and confidentiality in document management practices.

GKOSUS

ABOUT US

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.

Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS".

Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

Glaukos Corporation is an Equal Opportunity / Affirmative Action Employer . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.