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Engineering Document Specialist II
Burlington, MA
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.
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.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
2 to 5 years
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