Quality Documentation Lead - SDLC & Compliance (Hybrid)

Alphanumeric; Lower Providence Township (PA); Hybride; USD 56 000 - 62 000; Plein temps

Résumé du poste

Alphanumeric is seeking an Assurance Specialist to support quality documentation and SDLC processes in a regulated technology environment. You will manage controlled documents, coordinate reviews, and ensure audit-ready records.

The role emphasizes collaboration with Quality, Engineering, and global stakeholders, with hybrid onsite work and a focus on maintaining compliant, traceable documentation across the SDLC.

Qualifications

• Bachelor's degree in a scientific discipline or related field.
• Approximately 3-5 years of relevant experience in quality documentation, document control, or a related compliance-focused role.
• Hands-on experience managing controlled document lifecycles within a QMS / eQMS environment.
• Working knowledge of SDLC including Agile, Scrum, or waterfall methodologies.
• Experience supporting SDLC documentation such as requirements, specifications, tests, or release docs.
• Proficiency with document repositories and version control tools (e.g., SharePoint, Confluence, Jira).
• Strong technical writing, proofreading, editing, and formatting skills.
• Experience coordinating document reviews and approvals across multiple stakeholders.
• Familiarity with quality risk tracking, CAPAs, deviations, and audit readiness.

Responsabilités

• Support end-to-end documentation lifecycle for engineering activities.
• Coordinate with Quality, engineers, and stakeholders to obtain docs and secure timely approvals.
• Review technical documentation for accuracy, clarity, formatting, and completeness.
• Maintain controlled documentation repositories and version histories for traceability.
• Track deliverables, approvals, and actions to meet deadlines.
• Assist with CAPAs, risks, incidents, and related records.
• Support SDLC documentation including requirements, specs, testing, and release docs.
• Coordinate document routing, uploads, and finalization in QMS systems.
• Provide regular progress updates and elevate documentation or compliance concerns.
• Collaborate with cross-functional teams including international stakeholders.

Connaissances

Quality documentation

SDLC understanding

Document control

Cross-functional collaboration

Technical writing

Formation

Bachelor's degree in a scientific discipline or related field

Outils

Jira

Confluence

SharePoint

Description du poste

Alphanumeric is seeking an Assurance Specialist to support quality documentation and SDLC processes in a regulated technology environment. You will manage controlled documents, coordinate reviews, and ensure audit-ready records.

The role emphasizes collaboration with Quality, Engineering, and global stakeholders, with hybrid onsite work and a focus on maintaining compliant, traceable documentation across the SDLC.