Qa Engineer Regulatory Affairs

PETKO TODOROV QA Engineer, Regulatory Affairs Specialist and ISO Auditor

**** ****** **. # *** **** phone: 408-***-****

Sunnyvale, CA 94089 *******@*****.***

SKILLS, ABILITIES AND QUALIFICATIONS

More than 20 years of experience in Quality Engineering role in High Tech industry and Medical Device manufacturing as QC, QA, Test Engineer and Regulatory affairs specialist positions.

Certified ISO 9000 & 13485 Auditor with all successful certification and re-assessments by the agencies.

Strong Mechanical, Electrical and Software tool inspection background – proficient in a wide range of inspection and test methods, reliability and reproducibility study and software verification.

PROFESSIONAL EXPERIENCE

QA Engineer, ISO Auditor May 2015- Jan 2025

Nidec Genmark Automation, Fremont CA

• Managed and maintained the company’s Document Control system and the ECO process

• Defined, developed and implemented quality control procedures (Receiving inspection, In- process inspection and testing, final product QC inspection sheets) within the manufacturing process. Trained QC personnel.

• Investigated the failures originated from the RMA process and any other customer complaints

• Coordinated, conducted, and documented the supplier approval process and supplier performance review.

• Issue certificates of conformance to the customers. QA Engineer, ISO Auditor April 2015- May 2021

Inphenix, Livermore CA

• Conducted internal and critical supplier audits to ISO 9001:2015, communicated and coordinated customer QMS audits.

• Regularly recommended and presented quality objectives, which allowed for significant productivity gains and increased problem resolution.

• Facilitated and managed the Corrective Action (CAR) process. Verified the effectiveness of the actions taken. Conduct MRB (Material Review Board) meetings.

• Coordinated, conducted, and documented the supplier approval process and supplier performance review.

QA Engineer, ISO Auditor Dec 2010-Jan 2015

Ni-Ti Tubes, Fremont CA

• Defined, developed and implemented quality control procedures (Receiving inspection, In- process inspection and testing, final product QC inspection sheets) within the medical device manufacturing process. Trained QC personnel.

• Conducted internal and critical supplier audits to ISO 9001:2008, communicated and coordinated customer QMS audits. Developed SOP procedures per the industrial standard requirements.

• Regularly recommended and presented quality objectives, which allowed for significant productivity gains and increased problem resolution.

• Facilitated and managed the Corrective & Preventive Action (CAPA) process. Verified the effectiveness of the actions taken. Participated in MRB (Material Review Board).

• Investigated the failures originated from the RMA process and any other customer complaints Performed final quality inspection of the products; provided certificates of conformance to the customers.

QA & Regulatory Affairs Specialist, ISO Auditor Jan 2009-Sep 2010 Suni Medical Imaging, Inc., San Jose CA

• Conducted internal and supplier audits to ISO 13485, ISO 9001, Canadian MDR, MDD93/42ECCstandards and FDA requirements. Facilitated and communicated the external assessment and re-assessment audits by the US and EU regulatory bodies and code officials.

• Maintained the Corrective & Preventive Action (CAPA) process.

• Coordinated the efforts of Engineering and Purchasing teams to ensure accuracy of the documentation support. Interfaced with outside vendors in respect to various quality issues.

• Managed test equipment and tools calibration process - in-house and outside calibration. QA Engineer Jan 2004–Nov 2008

Genmark Automation Inc., Fremont CA

• Developed and implemented inspection process and sampling procedures for reviewing critical mechanical and electrical parts and components. Designed various software tools for recording, evaluating and reporting quality data.

• Facilitated daily Material Review Board meetings including immediate distribution of the materials and follow up, solving manufacturing and other technical issues. EDUCATION

Sofia State University, Bulgaria, Faculty of Mathematics and Computer Science CERTIFICATES AND COURSES

• Mar, 2009 ISO 13485 and MDD 93/42/EEC certified auditor, Altoviya LLC, Daly City, CA-USA

• Nov, 2000 ISO 9000 certified auditor, top of class, Perry Johnson Inc, Southfield, MI –USA

• Dec, 1994 Geometric Dimensioning & Tolerance and Metrology, DEA, Torino- Italy

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