Medical Device eQMS Solutions Consultant

Grand Avenue Software; Polska; Hybrid; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Hybrid/remote work environment

Travel to industry events

Professional development opportunities

Comprehensive benefits

Job summary

Grand Avenue Software is seeking an energetic quality professional to serve as the go-to expert for demonstrating and explaining our eQMS software to medical device manufacturers, with a focus on ISO 13485:2016 and MDSAP during live demos.

You will drive pre-sales activity, respond to RFIs/RFPs, run live demos, map regulatory requirements to software capabilities, guide compliance during implementation, and collaborate closely with sales teams to close deals and ensure smooth onboarding.

Qualifications

• 4+ years of hands‑on experience in quality assurance / quality systems within the medical device or life sciences industry.
• Direct work on ISO 13485:2016 compliant QMS and participation in or support of ISO 13485 and MDSAP audits.
• Ability to multi-task and manage technical and interpersonal functions in sales environments.
• Experience with eQMS platforms including the named systems or similar.

Responsibilities

• Deliver live and virtual product demonstrations tailored to ISO 13485:2016, MDSAP, FDA 21 CFR Part 820, and other compliance needs.
• Respond to RFIs/RFPs and answer detailed questions about software functionality, compliance mapping, validations, workflows, and integrations.
• Develop demo content, qualify opportunities with account teams, and address objections related to quality system requirements.
• Conduct gap analyses and compliance mapping to show audit readiness during sales and early implementation.
• Guide post-go-live success, address advanced questions, and optimize for compliance and ROI.
• Create sales enablement materials including demos, whitepapers, use-case examples, and knowledge base articles.
• Represent the company as a subject matter expert in webinars, trade shows, and industry events.

Skills

Quality assurance

ISO 13485:2016

MDSAP audits

eQMS platforms

Presentation skills

Sales support

Regulatory translation

Education

Bachelor's degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, or related field

Tools

Grand Avenue Software

Greenlight Guru

MasterControl

Qualio

ETQ

Job description

Grand Avenue Software is seeking an energetic quality professional to serve as the go-to expert for demonstrating and explaining our eQMS software to medical device manufacturers, with a focus on ISO 13485:2016 and MDSAP during live demos.

You will drive pre-sales activity, respond to RFIs/RFPs, run live demos, map regulatory requirements to software capabilities, guide compliance during implementation, and collaborate closely with sales teams to close deals and ensure smooth onboarding.