Quality Assurance Lead (Medical Devices/ SaMD) - Katalyst Healthcares & Life Sciences
Waukegan, IL 60031
About the Job
Responsibilities:
- Perform QA activities related to Software as a Medical Device (SaMD) and Digital Health Software Product Development.
- Ensure compliance with company's software lifecycle policies and procedures.
Perform design control and risk management activities according to company's Quality System. - Partner with technical teams to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met.
Support the creation of regulatory submission documentation. - Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
- Initiate assignments independently. Actively lead and participate on development and process improvement teams.
- Anticipate/resolve quality issues and take preventative actions.
Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. - Write/review policies/processes/procedures and related documents for the development of SaMD's and Digital Health products in compliance with global regulations.
- Apply knowledge of global regulations, guidance's, and Corporate and Function standards.
- Lead/assist in the preparation of and support regulatory agency and internal audits.
- Bachelor's degree or equivalent is required; preferably in sciences, engineering or other technical/scientific area.
- Strong industry experience in Quality Assurance, Development or healthcare related field.
- Experience in Medical devices, specifically development of Software Medical Devices is desired.
- Strong understanding of regulations and standards affecting software medical devices such as IEC 62304, 21 CFR 820.30 and EU MDR.
- Experience with creation and maintenance of QMS documents for development of medical devices.
- Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills.
- Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation).
- Practical experience in design control and risk management.
- Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues.
- Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities.
Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required. - Capable of clearly presenting and justifying quality requirements to management.
Source : Katalyst Healthcares & Life Sciences