Roman Padilla

*** ****** ***., ******* **, ***** ac3f34@r.postjobfree.com

Objective Quality Management position responsible for overseeing and implementing quality assurance and controls within a company committed to quality. Skilled Quality Management Systems leader with expertise in Quality Assurance in the Medical Device industry.

Experience

February 2010 to December 2016 Solta Medical, Hayward, CA

Sr. Quality Assurance Manager

Ensuring that the quality system requirements are effectively established and effectively maintained and measured in accordance with US and international regulations.

Provide interpretation of regulations and standards in support of continuous improvements to the Solta Quality System in accordance with all applicable US and international regulations. Ensuring standards and regulations are current.

Ensuring that the Quality Policy is maintained and understood by all employees.

Reporting on the performance of the quality system to management with executive responsibility.

Responsible for compliance with regards to ISO 13485

Responsible for compliance to 21 CFR Part 820 FDA – Good Manufacturing Practices for Medical Devices.

Achieved Internal Audit Certification

Responsible for performing Internal Audits as required to maintain quality system requirements.

Responsible for supporting investigations for CAPAs issued.

Providing support to the Complaints Management process.

Primary responsibility for supplier quality engineering, supporting supply chain activities.

Perform evaluation and audits of suppliers and contractors. Maintain the annual supplier audit schedule.

Maintaining the Approved Supplier List (ASL) and supporting supplier scorecard process.

Review supplier/contractor and internal change orders for adequacy.

Perform Annual Supplier Reviews as part of Supplier Management and Control activities

Perform and support complaint related activities.

Provide technical support for risk assessment and updates to risk

Management files

December 2005 to February 2010 Aesthera Corporation, Pleasanton, CA

Sr. Quality Assurance Manager

Responsible for managing company’s Incident reporting process, including failure investigation tracking and trending activities, reporting, etc.

Responsible for all regulatory matters pertaining to company’s registration with external regulatory bodies, including but not limited to: TUV and FDA.

Responsible for all regulatory submission and registration to foreign governments for International product distribution

Responsible for compliance with regards to cGMPs, TUV, ISO 13485, Canadian requirements, etc.

Successfully implemented ISO 13485 in October 2008, where ISO Certification was awarded to Aesthera.

Ensured that internal and external quality assurance documentation adequately evaluated products and processes, including submissions to regulatory authorities.

Established and monitored supplier compliance programs as well as Quality Management System processes; developed and implemented audits of external raw material suppliers, contractors, collaborators, and other relevant organizations as needed.

Collaborated efforts with Senior Leadership to implement total quality management systems within company.

Developed and implemented audits and audit schedules, and recommended and assisted in development of corrective actions, as necessary.

Created and maintained quality assurance databases, reports, and files.

Coordinated with engineering, operations, and other appropriate departments in development of Design History File and other required design transfer data and systems to ensure integrity and quality of submitted data.

Maintained and educated staff on current knowledge of government and industry compliance standards.

Provided expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance.

Collaborated with research and development during new product start-ups and product development; established key checkpoints for new products and processes; managed QA release of products for distribution.

Hired, trained, supervised, motivated, and developed quality assurance staff and worked as a lead team member in the manufacturing department.

Assured staff conformed to organizational policies.

Provided day-to-day guidance and oversight of subordinates; actively worked to promote and recognize performance.

Kept employees up to date on overall activities of the team, identifying problem areas and taking corrective actions.

Successfully reviewed and updated ISO 13485 and FDA related documentation to reflect current practices at Aesthera Corporation.

Familiar with Salesforce database; a web-based software application for tracking Customer product inquiries for Aesthera’s medical devices.

August 2005 to September 2005 Aesthera Corporation, Livermore, CA Quality Assurance

Successfully reviewed and updated ISO 9000 related documentation to reflect current practices at Aesthera Corporation.

Contributor and participant in Aesthera’s FDA audit, where successful results were reported.

FDA certification awarded to Aesthera.

Ensure compliance with all quality and certain regulatory requirement

Education/Certifications/Training

Bachelor’s of Arts, Speech and Communication from California State University, Long Beach

ISO 9000 Lead Assessor

ISO 13485 internal auditor.

Familiar with USA FDA 21 CFR 820 cGMP’s

Canada Health and European Union Medical Device regulatory requirements.

Software Applications: Microsoft Office, Excel, Word, PowerPoint, Flow -charter, Access, Omnify / Ematrix-Product Data Management (PDM), online Documentation Systems. Salesforce,( a web-based software application for tracking customer data), CATSWeb (customer complaint Database), Agile (PLM DB), Peoplesoft (PLM).

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