Shahan Stephanian

Cell: 626-***-****

ad1796@r.postjobfree.com

**** ******** ***.,

Pasadena, CA 91107

Summary:

A Project Leader Quality/Regulatory Affairs professional with over 9+ years of GMP experience working for Medical Devices companies; managing in FDA 21CFR Parts 210, 211 and 820 Quality System Regulation, ISO 9001, ISO 14971, ISO13485 quality systems as well as internal and external audit functions; providing oversight role to lead the Quality Systems and Supplier Management of the Ophthalmic, Surgical & Vision Business Instruments and IOL products, Home Care Oxygen Therapeutics, IVD Diagnostic, and Hard Valve Medical Device products. The role includes three key functional leadership aspects:

As effective and analytical result-oriented leader in decision making, problem solving, and team building skills with strong knowledge of domestic and international regulations including CMDR, EUMDR, ANVISA, KFDA, JPAL, Clinical Laboratory Standards Institute (CLSI), MDR and IVDR standards.

Designed Assurance and New Product Development Life Cycle, Quality Compliance and Management Representative including Process Validation, and New Suppliers selection, qualification, and monitoring activities. The individual represents the management of quality system regulations, establishes appropriate policy and guidelines to ensure lasting customer satisfaction.

Extensive experience releasing complex products and remediation projects requires the ability to make sound decisions based on scientific and regulatory knowledge.

Highly efficient quality project-management such as scheduling project plan and risk matrix skills; manages multiple priorities within demanding environment. Hosted and managed several FDA inspections and Notify Body audits (front and background rooms). Qualifications:

Subject Matter Expert in the following Quality core competencies:

Design Control

Risk Management

Test Method Validation

Statistical Methodology

DMAIC Methodology

CAPA/NCR

Skills:

Computer Software skills and languages: MS Word, Assembly language, Reliability RELEX (reliability software program), EDMS, Minitab Statistical Software, CMM, and Smart Scope programs. Education:

Bachelor's Degree in Science – Applied Physics

o California State University

STAT-A-MATRIX Institute - Huntington Beach, CA

LSI Semiconductors Technology at UCLA

Certifications:

Certified GMP/ISO 9001/13485:2003 Internal Auditor, sponsored by STAT-A-MATRIX Institute.

Certified ISO 9001 Auditor/Lead Auditor, sponsored by (QASNA) Huntington Beach – California

Certified “VLSI/LSI Semiconductors Technology” UCLA short courses program – California

Certified “Six-Sigma - Green Belt” by Bausch & Lomb program.

Certified Supplier Quality Auditor by Bausch & Lomb program.

Certified Problem-Solving Process (PSP): Dive by Danaher Corporation.

Certified Kaizen training program by Danaher Corporation.

Certified Product and Non-Product Software Beckman Coulter System (including GAMP 5 and Software Risk Assessment) – provided by Danaher Corporation Professional Experience:

Cognos Therapeutics Inglewood, CA Jan 2020 – Present Principal Quality Engineer & Regulatory Compliance Product Line: Implantable Infusion Pump System and Accessories

Apply knowledge of Design Control principles and quality engineering techniques to positively influence product development efforts, including those for Risk Management, Human Factors, Specification Development, Design Verification, and Design Validation.

Leads risk management activities throughout the product life cycle, including Hazard Analyses, Design Failure Mode & Effects Analysis (DFMEAs), Process Failure Mode & Effects Analysis (PFMEAs), and Use Failure Modes & Effects Analysis (UFMEAs). Ensures appropriate statistical methodology is employed during development efforts.

Work with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability.

Provide guidance for the combination products in development and manufacturability and assure the regulatory and quality requirements are attained.

Drive predictive engineering methodology incorporating reliability and capability analysis assessments in device design control and manufacturing processes.

Ensures test methods validation process and drug-device stability studies are appropriate and validated for use.

Participate actively as contributor for the FDA pre submission projects.

Work with product safety and biocompatibility test laboratories to comply with applicable regulatory compliance and standards.

Hybrid Systems Corp - Glendale, CA Dec 2018 – Jan 2020 Quality Assurance Manager - Contract Manufacturer for Medical Devices and Commercial Products

Oversaw the daily quality systems task assignments of direct reports as well as supervise and prioritizes tasks as necessary to assure schedule compliance.

Implement ISO 14971:2019 relates to 21 CFR 820, ISO 13485:2016, and the MDR 2017/745

Prepare and execute product and non-product software validation protocols and reports to comply the customer's policy and procedures, which is in compliance with EUMDR requirements.

Prepare Software Requirement Specification (SRS), and Software Hazard Analysis per applicable standards and procedures.

Managed and oversaw all inspections of parts, investigates non-conformances, initiates, implements, and coordinates corrective and preventative actions as appropriate.

Performed Interface with design, inspection and manufacturing personnel on technical issues, specification requirements, inspection methods and scheduling.

Reviewed and approved all revisions to internal process procedures and Quality system procedures to assure that documentation meets current regulatory and customer requirements. (ISO 13485:2016 / ISO 9001:2015 and, IEC/MDR Standards).

Scheduled and reviewed internal and external audits to assure that any out of compliance with product, processes, or procedures are identified, documented, recorded, and corrected. Represented Company during all customer and regulatory audits. Reviews all data obtained during all quality control and quality assurance activities to ensure consistency with company goals, policies, and procedures.

Kept management team abreast of significant issues or developments identified during quality activities and CAPA actions being taken to assure continuous process improvement.

Designed and implemented training programs to all quality and production personnel.

Investigated customer complaints regarding quality problems. Johnson & Johnson Surgical Vision - Santa Ana, CA Mar 2018 - Nov 2018 Lead Design Quality Specialist/Quality Systems Engineer Product Line: Cataract Surgery, Laser Surgery, and Consumer Eye Health products

Full Remediation of DHF, RMF and HFEs for CEH, Capital Equipment, IOLs and Third-Party Manufacturers.

Supported the development for Design Trace Matrices for between customer requirements, design input, design output, design verification, design validation and design transfer.

Developed/Updated Risk Management templates and processes, which includes the Risk Management File gap assessment and remediation.

Performed Design History File Gap Assessment and Remediation, and Human Factor Engineering Gap Assessment and Remediation projects.

Beckman Coulter Inc - Chatsworth, CA Nov 2014 - Jan 2018 Staff Design Quality Engineer

Product Line: In Vitro Diagnostic (IVD) Urinalysis Systems, Reagents and Consumable

Directed, developed, and executed strategic planning that directs Design Quality activities and aligns with the Quality Systems, New Product Development, New Supplier Selection and Monitoring, Internal and External Audits, Regulatory projects.

Prepared and maintained Design History File (DHF) for Remediation projects according to the Company strategies that include the extended projects for FDA 510K submissions and updating the Technical Files per applicable EU standards. All Remediation verifications, clinical performance evaluation and product validations protocols are being executed at module, instrument, and system levels.

Provided leadership and compliance within Design Quality organization and capable of delivering on the objectives for New Product Introduction and business priorities.

Partnered with all functions including R&D, Clinical & Regulatory Affairs, Product Development, QA Ops and Program Management to translate software life cycle development (SLCD) and electromechanical system requirements into robust & consistent implementation practices.

Developed and maintained Design Quality, Risk Management and Reliability programs, processes that consistently assure product performance satisfies intended use and previously determined customer expectations.

Lead the on-going audit readiness of design related and quality systems, CAPAs, complaint investigations, and risk management support. Interfaces with external Regulatory & Audit Agencies in matters related to design controls and quality systems. Medtronic Inc - Northridge, CA Jun 2014 - Oct 2014 Quality System Engineer/Risk Management Specialist Product Line: Insulin Infusion Pump and Accessories

Reviewed and assessed risk Management documents, including FMEA and FTA, risk management plan and report and risk analysis documents, risk-benefit and assurance case reports.

Developed and implemented risk assessment techniques in compliance with IEC 60601-1 EN 62304, EN 62366 and ISO 14971 standards in supporting the Remediation of the risk management process.

Worked closely with cross-functional team in development of thorough, accurate and practical risk estimations, risk control measures and risk/benefit analysis.

Analysed production and field data for field returns and determine if the changes to product risk profile have occurred; initiate and coordinate risk control activities as required.

Updated legacy product risk management documentation to comply with current risk management process and meet the remediation plans and regulatory requirements. Dexterity Diagnostic, Inc - Rancho Dominguez, CA Dec 2013 - May 2014 Quality Assurance Specialist

Product Line: In Vitro Diagnostics (IVD) and Medical Device products

Developed written policies, procedures and work instructions required for building the quality system under IVD medical devices regulations.

Performed tasks required to support design control process, such as risk analysis, design verification, engineering change order and new supplier qualification and monitoring system.

Provided the software quality support to the LIMS software system (non-product software tools) for qualifying new software contractors.

Executed several software and hardware validation protocols for the installation of new temperature and humidity monitoring and control systems.

ResMed Motor Technologies - Chatsworth, CA Apr 2013 - Nov 2013 Quality Assurance & Regulatory Director (Acting)

Product Line: Sleep Apnea, Ventilator and Sleep Dental Implant products

Established clear processes and metrics in line with business strategy and regulatory compliance requirements.

Maintained External References and implement, per applicable national and international regulations, standards and FDA guidance documents that affect the products and operations.

Performed the role of management representatives and interface with FDA and Notify Body auditors.

Worked with R&D and Manufacturing to establish quality plans and ensure quality objectives are met.

Collaborated with CAPA Owners to manage CAPAs in the system to ensure they are well planned, effective, and completed in a timely manner.

Directed and managed strategic and tactical quality operations and supplier management for company.

Communicated group performance against established metrics to senior management.

Monitored proposed regulatory changes from the FDA and other agencies including worldwide regulatory authorities and provide management with impact of changes in the Regulatory environment. CORD, LLC Jul 2012 - Mar 2013

Quality System Manager (Contract)

Product: Implant Accommodating Intraocular lens (IOL) products and inserters.

Established, implemented, and sustained company's quality management system, and support the regulatory affairs, clinical outcomes, and supplier quality program.

Successfully gained the certification to operate the company under the ISO 13485:2012 quality management systems.

Responsible for the supplier quality management program; ensure new and current supplier selection, qualification, supplier audit is completed on timely manner.

Developed master validation plans and executes process validation protocols and reports in accordance with product and process specification requirements. Bausch & Lomb Corporation Rancho Cucamonga Site, CA Mar 2006 - Jun 2012 Quality Engineering System Manager

Product: Implant Intraocular lens product (IOL) /Injector devices/and Surgical Equipment

Ensured the R&D new and existing products development portfolio and sustaining of the current medical devices. Assures adequate resources are present to represent design QA function and to support the company growth. Provides leadership on product project management boards and works closely in conjunction with R&D, Regulatory Affairs, Clinical, Process, and Manufacturing.

Submitted to the FDA several 30-Days Notices, 135-Days Premarket Approval (PMA) Supplements for manufacturing method and process changes.

Ensured that all site quality performance indicators (QPI) metrics presented to the management.

Worked directly with operating entities to ensure that supplier management controls, product life cycle requirements including risk management, inspections, lean manufacturing, six-sigma, root cause analysis tools, statistical process control analyses and internal & external audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.

Established the development and maintenance of the quality assurance programs; policies, processes, procedures, and controls ensuring that performance and quality of products conform with establish standards and agency guidelines.

Reviews, analyses and reports on quality discrepancies related to products manufactured and works closely with manufacturing to develop disposition and corrective actions for recurring discrepancies.

Directed and coordinated all aspects of site strategic planning and quality assurance programs, such as development and administration, training, coaching employees, and facilitating through the organization.

Responsible for the organizational structure changes/alignment with B+L corporate quality system.

Responsible for managing the quality integration plan into the transformation Plan: NC/CAPA CAMS 2.0, Change Management, Documentum 6.5 and Compliance Wire.

Performed Quality Planning Tool to assess site quality systems versus global supplier quality system and where needed make appropriate changes to the local quality systems.

Represented the site externally with domestic and international regulatory agencies to provide information and solve problems.

Developed and implemented procedures for inspecting, testing and evaluating the precision, accuracy, 1st Article Inspection, and reliability of new and current suppliers' products.

Monthly reporting to the senior functional management on the CAPA/NC and Complaint handling performance and other quality system activities.

Managed site internal and external audit preparation ensuring all elements of quality systems are being managed effectively and in timely manner.

Participated in industry and regulatory surveillance to ensure that the highest standards are maintained through on-going communication and training.

Responsible for leading development and management of effective compliant quality systems, working closely with various cross functional members of site to ensure all requirements described meet the needs of regulations and functional excellence.

Assisted in the development and monitoring of department budget.

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