Job
- Level
- Experienced
- Job Field
- IT, Security, Test/QA
- Employment Type
- Full Time
- Contract Type
- Permanent employment
- Salary
- from 50.000 € Gross/Year
- Location
- Vienna
- Working Model
- Onsite
Job Summary
In this role, you analyze product quality for software medical devices and ensure compliance with international regulations while leading risk management planning and design validation projects.
Job Technologies
Your role in the team
- Execute activities for the Device Quality function supporting software medical device and combination products for all phases of the product lifecycle including design, development, manufacture, distribution, and product support processes.
- Ensure all device and combination product quality and regulatory standards/requirements are met.
- Provide quality support for, but not limited to, internal/external inspections, product submissions/approvals, CAPA, complaint handling, and change control.
- Represents DQ in support of Scarletred’s medical device and combination product development efforts (e.g., new software applications, changes to existing software applications, bug fixes, etc.) throughout clinical development, design transfer, and commercialisation.
- Accountable for DQ deliverables (e.g., risk management file documents, quality plan, trace matrix, software validation, etc.) in oversight of 62304 Class 1m, 2a and SaMD / decision support system.
- Accountable for risk management deliverables (e.g., risk management plan, FMEA, hazard analysis, risk management report) and quality planning activities for assigned projects.
- Responsible to ensure that assigned medical device and combination product development projects are in compliance to IEC 62304, MDR, ISO 13485, ISO 14971, and other relevant global regulations and international standards.
- Provides DQ technical quality support for regulatory filings in EU, USA and Japan.
- Provides DQ technical support including planning, execution, and reporting of design verification and validation activities for SaMD.
- Leads quality improvement initiatives and designs improvements within the lifecycle management of assigned medical devices or combination products.
- Responsible for quality assessment during supplier qualification for assigned development projects.
- Supports internal and external audits including readiness as an SME on product lifecycle documentation.
- Can effectively lead and execute commercial lifecycle management support activities including but not limited to change control, deviation investigation, CAPA, and complaint handling.
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Our expectations of you
Education
- Bachelor’s or Master Degree in Engineering or equivalent technical discipline required, and at least 5 years of experience working with software medical devices in Quality Assurance and/or Quality Engineering roles.
- Advanced Degree and Experience working in Pharmaceutical/Biotech/Device industry, Software Application Medical Device Engineering background preferred, Quality IT; Auditor certification.
Qualifications
- Extensive knowledge of international regulations for Device and Combination Products with full understanding of European, International, and US requirements for Design Control and Risk Management guidelines, Change Management, CAPA, with primary emphasis on ISO 13485, ISO 14971, MDR and IEC 62304.
- Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team.
- Strong decision-making skills even in times of uncertainty.
- Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs.
- Ability to work productively on a cross-functional team model.
- Build strong working relationships with Device Quality partners and other business process owners.
- Accountable for analyzing product information, driving improvements in process as a result of product knowledge.
Experience
- Experience with commercial development and regulatory filings.
- Experience working with external manufacturing partners.
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Job Locations
Topics that you deal with on the job
This is your employer
SCARLETRED Holding GmbH
Wien
Scarletred is the certified medical device product that solves the problem of lacking standardization and objectivity in Teledermatology. The AI powered software enables high quality remote skin imaging and analysis in a multitude of skin conditions, supplying international Biopharma and Cosmetics companies, governments hospitals and clinicians.
Description
- Company Type
- Established Company
- Industry
- Internet, IT, Telecommunication
Software Medical Device Quality Engineer
- Salary
- from 50.000 € Gross/Year
- Location
- Vienna
- Working Model
- Onsite
- Diversity
- Open for all genders
