Phyo Soe Email & Phone Number

Minneapolis, Minnesota, Us

Tempe, Arizona, Us

• Served as QA representative for software development projects for production software as well as SaMD.• Collaborated with NPD cross functional team and launched a new SaMD product with AI/ML component in New Zealand and in Australia.• Ensured SDLC documentations are complete per IEC 62304 requirements.• Created/Updated risk assessments of medical device software per EN ISO 14971:2019 requirements.

Briarcliff Manor, New York, Us

• Managed ISO 13485:2016 MDSAP surveillance audits and any follow-up corrective actions.• Facilitated IBRACE Brazilian Certification audits.• Prepared ASEAN CSDT Files for Malaysian and Singapore device registration and successfully received license approvals.• Coordinated device labeling update for inclusion of various EU language translations.• Managed transfer of products to Propel’s QMS after acquisition of a competitor company.• Performed supplier audits as lead auditor.

Briarcliff Manor, New York, Us

• Implemented CAPAs to address nonconformities from previous year ISO 13485:2016 transition audit.• Wrote SDLC documentations for 510k submission of Class II orthodontic vibration device per IEC 62304.• Worked with Emergo consultants to upgrade Propel’s QMS to be compliant to MDSAP.• Prepared and submitted Class IIa technical file to the notified body for inclusion of the new product in CE certification.• Investigated and documented reports on product complaints and nonconformities. • Compiled Post-Market Surveillance Report and hosted Management Review meeting.• Performed gap analysis and updated procedures to be compliant with EU MDR Transitional Provisions.• Facilitated ISO 13485:2016 MDSAP certification audit.

Waltham, Ma, Us

• Performed gap assessment to transition site QMS from ISO 9001:2008 to ISO 9001:2015.• Updated site SOPs to meet ISO 9001:2015 standard.• Reviewed complaints and initiated CAPAs on Trackwise as necessary.• Performed internal audits for various departments to ISO 9001: 2015.• Hosted weekly meetings with colleagues from different functions to drive CAPA projects to completion.• Worked with supplier quality engineer and purchasing team to resolve nonconforming materials issues from suppliers.• Performed gap assessment for site QC function from ISO 9001:2015 to ISO 13485:2016.

Santa Clara, California, Us

-Responsible for post-market surveillance activities for Class I and Class II medical devices.-Submitted MDR reports to the FDA for adverse events and device malfunctions.-Coordinated corrective actions indicated in the CAPA and verified results of CAPA corrective actions.-Managed supplier quality activities.-Facilitated ISO 13485 audits from Notified Bodies. (Surveillance, Re-certification, Transfer, Scope Extension)-Facilitated Korean MFDS GMP audit.-Compiled an EEE product technical file for CE mark.-Supported submission of 510k for Class II medical device software.-Supported EC certification of Class Im medical device software.-Maintained document control and manage revision change process.-Conducted internal audits and present finding in management review meeting.

Santa Clara, California, Us

-Scanned in dental stone models using optical scanners.-Post-processed 3D printed dental models.-Fabricated surgical guides used by oral surgeons to assist with their dental implant surgery.-Performed quality checks for the surgical guides.

Master Of Science - Ms, Regulatory Science

Bachelor Of Arts - Ba, Cell/Cellular And Molecular Biology