Process Development Consultant

Alpharetta, GA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Description:

Key Focus: FDA experience is highly valued especially if youve led process revamps or redesigned processes reviewed and validated by the FDA.
Join a team driving medical device quality and process development bridging compliance requirements and real-world business needs. Youll lead the creation and revision of procedures collaborate directly with business process owners and transform evolving requirements into clear actionable documentation.

Responsibilities:

Process Development & Documentation: Write and revise procedures specifications and user needs documents to create user-friendly compliant processes.
Quality System Support: Manage NCRs CAPAs and quality manufacturing records. Apply design controls through development and design transfer.
Regulatory & Standards Compliance: Ensure alignment with ISO 13485 FDA requirements and post-market/field action processes.
Risk & Design Quality: Support risk documentation and design quality initiatives.

Requirements:

Strong process writing skills-turning complex workflows into structured clear documentation.
Ability to work with stakeholders to clarify and prioritize evolving needs.
Knowledge of SAP vs. QMS touchpoints and how they interact in product realization.
Proven track record in FDA-regulated environments and medical device quality.
Ability to create software guidelines from processes (in business terms not overly technical).
Balanced approach to compliance-ensuring quality while keeping processes practical and usable.

Job Description: Key Focus: FDA experience is highly valued especially if youve led process revamps or redesigned processes reviewed and validated by the FDA. Join a team driving medical device quality and process development bridging compliance requirements and real-world business needs. Youll lea...