Jobs at Rose Medical

Rose Medical is a fast-growing medical device manufacturer dedicated to producing high-quality, innovative products that make a difference in people’s lives. We are seeking a Quality and Regulatory Specialist to manage and continually improve our Quality Management System while ensuring compliance with ISO 13485 and FDA regulations.

• Manage third-party audits (ISO 13485, customer, and FDA inspections).
• Lead and execute the CAPA process, ensuring timely and effective resolution of issues.
• Maintain and manage the Approved Supplier List and supplier controls.
• Coordinate and execute internal audits and QSP training programs.
• Keep presentations and documentation current while conducting training sessions.
• Coordinate and manage equipment calibrations and environmental condition reviews.
• Stay current with ISO and FDA GMP standards, implementing new requirements as needed.
• Provide measurement and analysis data for management review and quality objectives.
• Assist with contractual documentation (quality agreements, NDAs, etc.) and document control.
• Support the engineering team with process validation and risk management activities.
• Investigate nonconformances, coordinate corrective actions, and follow through to prevent recurrence.
• Complete customer surveys and other compliance documentation as required.

• Bachelor of Science degree or equivalent combination of education and experience.
• 5+ years of experience in a Quality Systems role, preferably in medical device manufacturing.
• Strong working knowledge of ISO 13485 and FDA QSRs.
• Experience with CAPA, supplier controls, audits, validation, and risk management.
• Solid understanding of basic statistical and engineering principles.
• Ability to thrive in a fast-paced environment and manage multiple priorities effectively.
• Excellent communication and collaboration skills; positive, team-oriented mindset.
• Familiarity with Product Data Management systems preferred.