James Lee Cano

Address: *** ****** ******* *********, **. 92029

Mobile: 310-***-**** / e-Mail: ad2p9r@r.postjobfree.com ACCOMPLISHMENTS:

- Managed and participated in continual improvement, new product development and cost reduction programs in order to structure assembly lines, minimize inventory levels and improve inspection efficiency.

- Set-Up and manage Maquiladora (offshore) operation in Mexico and project planning in Ireland producing commercial and medical goods.

- Led and participated in the attainment of ISO 9001 and ISO 13485 certification while working for and with industry recognized registrars (BSI, TUV, Intertek, SGS, GMED, DEKRA, Perry Johnson).

- Perform Qualification and Validation of electronic business system software for multiple organizations utilized in managing and conducting operations.

- Create Quality Manuals, operating procedures, work and test instructions, specifications and forms for Quality Management Systems in order to meet ISO and FDA/GMP compliance and/or preparation for certification.

- Represent the Quality Assurance Department in the participation of Design and Development and Product Transfer Meetings in order to transfer product to Manufacturing Sites. PROFESSIONAL EXPERIENCE:

* Mast Biosurgery USA, Inc. (San Diego, CA.); (Leading in the design, development, and production of bioresorbable polymer implants, and emerging new technologies for use in a variety of surgical applications within the biosurgery market);

* Currently employed as permanent position to provide Quality Assurance Manager to support

- Quality Assurance Manager; September 2022 to Current

- Designated as Management Representative to develop, train, audit and manage ISO 13485:2016 Quality Management System and Medical Device Regulation (CE Marked) product.

- Participation in Management Meetings addressing Research and Development and New Product Development, MRB (NCMRs), Supplier Audits, CAPAs, Complaint Status and Internal and External Audit Findings.

- Responsible for generating Procedures, Work Instructions, Forms and Specifications including oversite of Document Control and Quality Engineering support of testing and development projects.

* Pacific Biosciences of California, Inc. (San Diego, CA.); (Creator of the world’s most advanced sequencing systems which provide the most complete and accurate view of genomes, transcriptomes, and epigenomes, including invention of a new way to study the synthesis and regulation of DNA, RNA, and proteins);

* Contract assignment to provide Quality support for Biotech Facility, resigned to take permanent position.

- Quality Assurance Manager (Contractor through Agency); July 2022 – September 2022

- Assigned as Quality Representative to develop, train, audit and manage ISO 9001:2015 Quality System.

- Oversee Agile software system to manage Document Control, Change Control, Deviations NCPs, CAPAs, SCARs and Complaint investigation for San Diego, CA. Site.

- Participation in Management Meetings addressing Research and Development and New Product Development, MRB (NCMRs), Supplier Audits, CAPAs, Complaint Status and Internal and External Audit Findings.

- Perform reviews and provide input on first Articles, validations, procedures, work instructions and forms in support of Contract Manufacturing Organizations and Corporate Site R&D (Menlo Park, CA.).

* NexusDx, Inc. (San Diego, CA.); (A clinical diagnostics company providing rapid and reliable information using quantitative marker assays at the Point of Care);

* Month-to-month contract assignment with Biotech Manufacturing Company, ended due to production slow down and lack of sales.

- Manager, Quality Assurance; December 2021 – June 2022

- Assigned as Management Representative to develop, train, audit and manage ISO 13485:2016 Quality Management System Certification and In-Vitro Diagnostic Regulation Product CE Marking.

- Oversee MasterControl software system to manage Document Control, Change Control, Issues which escalate to NCMRs, CAPAs, SCARs and Complaint investigations.

- Participation in Management Meetings addressing Product Development, MRB (NCMRs), CAPAs, Issues, Complaint status with German Supplier and Internal and External Audit Findings.

- Prepare weekly reports for internal performance reporting (KPIs, Quality Objectives, Department Metrics).

* MPS Medical, Inc. (Brea, CA.); (Develops and manufactures medical devices to advance healthcare across multiple areas of care including infusion therapy, cell therapy manufacturing, sterile compounding, COVID-19 Test Kits and in-home pharmacy, as well as OEM services);

* Parents had retired and resigned to take position closer to home to support family.

- Quality Systems Manager/ISO Coordinator; June 2021 – November 2021

- Assigned as Management Representative to develop, train, audit and manage Medical Device Single Audit Program (ISO 13485:2016) Quality Management System.

- Oversee document control system in order to release, approve and control document changes.

- Preparation and support of Contract Manufacturing Organization activities to support the production of COVID-19 Antigen Test Kits and future design and development of internal test kits.

- Prepare and manage NCMR, CAPA, SCAR and Complaint handling processes involving Suppliers and Customers

- Communicate and Coordinate with FDA (Regulatory Agency) on stablishing export licenses, company and product registrations.

* Zume, Inc. (Camarillo, CA.); (Spearheading the switch from plastic to compostable molded fiber packaging through its patent pending manufacturing technology and its network of global suppliers. Uniquely designed and patent pending products that function like plastic and are made from various biomass sources such as bagasse. Customers span across food service / restaurants, FMCG and healthcare);

* Bay Area start-up experienced cutbacks and work force reduction due to slow Customer sales and contracts.

- Quality Manager; September 2020 – May 2021

- Manage department of Q.C. Technicians in the support of manufacturing and design and development operations, including daily testing, physical and visual inspection of compostable (molded fiber) masks

(commercial and N95) and various types of compostable food packaging.

- Develop and set-up Quality System in order document processes and products manufactured and inspected.

- Participate in the qualification and validation of robotic and automated processes in the production of goods.

- Lead and manage NCMR, CAPA, SCAR and Complaint handling processes involving Suppliers and Customers.

- Conduct facility audits in order to prepare organization for HACCP Certification (Food Manufacturing).

* BSI Group America, Inc. (Escondido, CA./Herndon, VA.); (BSI Group America is a company that specializes in business services. It provides management system solutions with a focus on quality management certifications, supply chain, training programs, advisory services and information technologies. The company delivers its services across aerospace, automotive, financial, healthcare, and other sectors);

* Resigned for opportunity to re-join industry in new compostable food packaging technology.

- Client Manager; October 2011 – August 2020

- Lead Assessor performing Quality System Audits of Medical, Commercial, Biotech, Dental, Defense and Aerospace companies to ISO 13485:2016, ISO 9001:2015, Medical Device Single Audit Program, Invitro Diagnostic Device Regulation and Medical Device Regulation.

- Train new auditors in the assessment of organizations attaining or being re-audited to ISO or MDSAP certification, includes product review in order to meet MDD or MDR requirements.

- Prepare Client Audit Reports based on Surveillance, Unannounced, Supplier and Re-Certification visits.

* LMA North America, Inc. (San Diego, CA.); (Marketing and Sales of products for anesthesia and critical care. The company also offers clinical education through airway seminars, visiting lecturer programs and hands-on workshops);

* Company closed and sold off resulting in work force reduction, offered position with 3rd Party Registrar.

- Senior Quality Assurance Manager; March 2004 – September 2011

- Responsible for assembling Quality System procedures, work instructions and forms in order to support distribution activities of various medical devices meeting CFR 820, ISO 13485 and regulatory requirements.

- Managed Document Control, Incoming, In-Process and Final Inspection and Service Departments.

- Perform first article inspection of components and finished products to support final product release.

- Prepare and manage NCMR, CAPA, SCAR and RMA handling processes involving Suppliers and Customers.

- Responsible for handling and processing RMAs through a service supplier.

- Supervise packaging and rework operations of accessory items and finished product.

* Discus Dental, Inc. (Culver City, CA.); (Leader in the dental industry in the marketing and distribution of premium aesthetic and clinical products to dental professionals. The company also provides practice building tools and services as well as expert industry training for the dental community);

* Moved back home to support family during slowdown of economy and company layoffs.

- Quality Assurance Manager/ISO Coordinator; April 2000 – February 2004

- Assigned as Management Representative to develop, train, audit and manage ISO 9000 Quality System.

- Manage Document Control, Change Control, Device Master Records and Device History Records.

- Acting Quality Engineer in support of product development and sustaining of new and existing devices and products rinses and formulations.

- Prepare and manage NCMR, CAPA, SCAR and Complaint handling processes involving Suppliers and Customers.

* Acutek Adhesive Specialties (Inglewood, CA.); (Strategic partner for turn-key medical device manufacturing services for the world’s leading companies in advanced wound care, consumer wellness and medical device fixation);

* Contract position ended due to company being sold off to competitor and later closed.

- Manufacturing Facilitator; September 1998 – April 2000.

- Develop operational U-Cell, Q.C. Inspection, packaging lines and tooling in order to support the manufacturer of various pressure sensitive components utilized in medical, commercial and aerospace applications.

- Responsible for managing Continuous Improvement Program to develop efficiency of in line inspections.

- Manage Customers and Suppliers to ensure internal and external Quality levels are met.

- Perform facility preventive maintenance, address requests for repairs and purchasing of supplies and tooling.

* Sony Electronics, Inc. (NPM); (San Diego, CA.); (Electronic products covering a wide variety of product lines in many areas. Product Development and Manufacturer of computing, audio, video and accessory items);

* Temporary agency position, later was called back to work for previous employer.

- Quality Control Engineer; May 1998 – September 1998.

- Hired, trained and managed inspection team to provide support of functional inspection, software (Microsoft) testing and final product release of consumer desktop computer workstation (Sony Vaio Computer).

- Participate in product development and sustaining of electronic consumer products and support software.

- Generate, maintain and manage document control of procedures, test instructions and technical documents.

- Prepare daily summary reports of inspection performance (first pass yield, non-conforming, vendor).

* Chad Therapeutics (Chatsworth, CA.); (Develops and produces oxygen-conserving devices and oxygen systems used by pulmonary patients who need supplementary oxygen. The Company's products are designed for use by ambulatory oxygen patients);

* Due to slow sales and failed next generation product, work force was reduced and later was laid-off.

- Quality Assurance Manager; September 1997 – March 1998.

- Managed Receiving Inspection, Document Control and Service Departments in support of portable oxygen.

- Develop Supplier performance program in order to establish ship-to-stock and Quality requirements.

- Assigned as Company Representative to the planning and development of the Quality Management System.

- Oversee Regulatory responsibilities involving FDA, UL and ISO organizations.

* White River Concepts (San Clemente, CA.); (Development of a lightweight electric breast pump, approved by the Food and Drug Administration with a soft silicone cup designed to be gentler on nursing women);

* Consulting assignment ended due to company being sold and later closed for re-organization.

- Quality Consultant; March 1997 – August 1997.

- Create procedures, work instructions and forms in order document the assembly, inspection and testing of electro-mechanical tabletop and portable breast pumps and accessories.

- Set-Up and maintain inventory control system, device master and history record files.

- Manage and perform document and change control, internal and external audits (GMP and Supplier).

- Participate in Design and Development activities surrounding Master Device Record creation.

* Acutek Adhesive Specialties (Inglewood, CA./Tijuana Mexico); (Strategic partner for turn-key medical device manufacturing services for the world’s leading companies in advanced wound care, consumer wellness and medical device fixation); s)

* Resigned position to start Consulting Business to assist organizations in attaining ISO Certification.

- Q.A. Manager / Facilities and Safety Manager / Customer Quality Manager; February 1992 – March 1997.

- Responsible for managing, documenting and performing all aspects of Quality covering Receiving, In-Process and Final Inspection of pressure sensitive components for medical, commercial and aerospace industries.

- Planning, set-up and technical support of offshore import, export operations in Mexico and Ireland.

- Design Quality Management System documents to meet GMP, Customer and ISO 9000 requirements.

- Perform procurement and purchasing of factory supplies and services to support factory operations.

- Manage, maintain and coordinate the calibration of tools and equipment to support manufacturing.

* Nellcor Incorporated (Chula Vista, CA.); (Nellcor™ pulse oximetry with OxiMax™ technology places the individual sensor's calibration curve in the sensor itself. The Nellcor™ OxiMax™ technology monitoring system incorporates a small digital memory chip within every Nellcor™ OxiMax™ sensor. This technology enables the monitor to deliver accurate SpO2 and pulse rate readings);

* Offered next level management position with Supplier in order to meet Customer requirements.

- Receiving Inspection Supervisor; May 1989 – February 1992.

- Supervise and report on Receiving Inspection department performance and employee development.

- Initiate and revise procedures, work instructions and forms to support receiving inspection of raw materials, electrical and mechanical components, sub-assemblies and Quality Software for Supplier Management.

- Chair and participate in MRB, CAPA and Supplier performance reporting and meetings.

- Participate in product transfer of new products from Design and Development site to local site.

- Provide inspection support and transfer of product at the Plant in Tijuana.

* Sutter Biomedical Incorporated (San Diego, CA.); (Manufacturer of various Human Body Prostheses-Namely, Prosthetic Joints, Sockets and Heart Valves; Instruments and Tools for Inserting Prostheses-Namely, Drills, Suture Passers, Heart Valve Inserter Sets, Extractors, Collets, Drill Guides, Chucks and Pins– Class II and III);

* Company was sold, moved and re-organized, offered opportunity to join large company.

- Q.C. Inspector / Production Lead / Q.C. Supervisor; June 1983 – May 1989.

- Perform receiving inspection of mechanical and electro-mechanical components and in-house machined components, in-process inspection of fabricated sub-assemblies and final inspection and test of sterile silicone implants, clean surgical instruments and durable orthopedic devices for the hand and knee.

- Chair and participate in MRB, ECO, DCO, Complaint and Production Meetings.

- Supervise employees at all levels of Inspection, Production and Final Product Release.

- Prepare and manage department budgets, calibration schedule and weekly production schedule.

- Perform scheduling and resource planning for inventory and purchase of materials.

* Spin Physics (Eastman Kodak Company); (San Diego, CA.) (Manufactured a line of high performance magnetic recording heads, and high-density magnetic diskettes for use with small computers);

* Due to Military cutbacks, resigned in to order to work in developing medical device industry.

- Q.C. Inspector; June 1978 – June 1983)

- Perform Receiving Inspection and First Article Inspection of electro-mechanical and mechanical components, in-house machined and fabricated components utilized in the final assembly of magnetic recording heads.

- Participate in DCAS performed inspections of assembled electro-mechanical assemblies.

- Experience in the use of mechanical inspection tools, fixed gages, air gaging equipment, optical inspection Equipment, electronic inspection equipment and monitors and color and finish standards.

- Provide input to Engineering in the creation of operating procedures, drawings and specifications. EDUCATION:

* Mesa Junior College

- Quality Assurance Technology Program (2 years)

* American Production and Inventory Control Society (APICS)

- Completed Inventory Management and Manufacturing Planning Courses

* San Diego Employers Association

- Certification of Completion for Supervisor/Management Course

* American Society for Quality (ASQ) and Other

- Completed Certification Courses in CGMP’s, ISO 9001 and ISO 13485, Plastics and Injection Molding, Medical Device Directive, Internal Auditing Geometric Dimensioning and Tolerancing, and Adhesives.

* BSI Group America, Inc.

- Certified Lead Auditor; ISO 13485:2016, ISO 9001:2015, Medical Device Single Audit Program (MDSAP), Invitro Diagnostic Device Regulation (IVDDR) and Medical Device Regulation (MDR); (CE Mark).

* Basic Computer Skills, Knowledge and Competency in Word, Excel, Visio, Microsoft Project.

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