Process Development Consultant
- Key Focus: FDA experience is highly valued, especially if you've 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. You'll lead the creation and revision of procedures, collaborate directly with business process owners, and transform evolving requirements into clear, actionable documentation.
- 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.
- 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.
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