Giovanni Angius - WIZBII Giovanni Angius has published his/her professional profile on WIZBII. G A

Giovanni Angius

Medical Device Design&Development Senior QA Engineer

44years • Lecco

Summary

I'm a Senior Quality Assurance Engineer for Medical Device Design and Development. My responsibilities starts from the first Quality Design Service Agreement until the Sustaining Activities after the devices are on the Market. My figure is a sort of Project Manager Quality Assurance, since I' involved in all the key decisions and I directly coordinate the engineering team. I'm responsible to ensure that the configuration is releases for the design&development builds to the manufacturing line.

Skills

Knowledge And Application Of The Following Standards And Skills: - ISO 13485, FDA 21 CFR Part 820 And Part 11, CGDP, CGMP - ISO TS 16949 And QS9000. - Automotive Manufacturing QMS Intensive Expertise On The Field And On The Production Lines. - MDD 93/42/CEE Medical Device Directive (MDD). - IVDD 98/79/EC In Vitro Diagnostic Directive (IVD). - ISO 19011 QMS Internal Auditor Certicate (TUV). - ISO 14971 Application Of Risk Management To Medical Devices. - ISO 60601 Series - ISO 11608 Series, RoHS And REACH Expertise. - ISO 10012, GUIDE 98-1 - ISO 17025 - PPAP, APQP, 8D, Incoming Inspection, Cp, Cpk, PPk Etc. Team Leader Of The Technical Engineers In Order To Manage: CAPA, NC, Clinical Trial Customer Complaints, Root Cause Analysis, Ishikawa Diagrams, 5 Why Approach, 4M, Lean Manufacturing Etc. Perform Internal Audit In Order To Verify The Compliance To Regulatory Or QMS Requirements And Project DHF Audits. Guide, Based On The Lifecycle Requirements, The Team Of Several Engineers In Order To Generate The Device Configuration, Engineer Change Request And Engineering Change Order. Interface The Whole Manufacturing Team, Step By Step, Following And Participating Actively In All The IQ, OQ, PQ. NPI (New Product Introduction) Device Release For Mass Production (process V&V). Visual Basic In Order To Create Several MS Windows Based SW Such As: - Process Equipment, Measurement Instrument Database Manager (calibration Due Date, Acceptance Criteria, Maintenance And Nonconformities Records), KPI Data Analysis And Reporting; - Automated Production Planning Aimed To Achieve The Cost Reduction Based On Sales Statistics And Batch Productions; - Several Programs To Manage Quality System: Instruments Handling And Work Process Cycle Automatic Generation. Ability To Predict Critical Situations Thinking And Finding What Could Solve Or Prevent The Issues To Overcome. PROJECT MANAGEMENT SKILLS I Lead The Team Of Mechanical, Electrical, Software, Device Testing And Industrial Designer Engineers, In Order To Ensure That The “rules Of The Game” Defined By Any Product Life Cycle R&D Are Met. I’m Used To Speak Effectively With The Team And Escalate Risks Or Issues When Necessary. Schedule Meetings To Resolve Issues And Define The Next Steps. Update The Project Manager About The Progresses Using A WBS (Work Breakdown Structure Scheme Approach). The Most Important Task Of A PM Is To Listen All The Team Members' Issues, Understanding Their Point Of View. More Eyes And Ears Can Catch What Yours Have Missed. I Perform 3 Minutes Team Building Before A Meeting Putting Everyone “against Me For Joke”, Providing Impossible Tasks. This Helps To Reduce The Stress Of The Engineers, Have A Little Break And Understand That Their Tasks Are Not So Unachievable. This Trick Works Also When There Is A Conflict In The Team. I Bring The Conflict To A Boring Discussion, Then I Put Some Interest On What Someone Said Before. The Next Step Is To Bring The Focus Of The Discussion On The Specific Argument In Order To Have Everyone To Agree On Something And Discuss It. The Conflict Became A Discussion With A Lowered Level Of Conflicts. Since I’ve A Technical And Business Management Background, I Would Like To Weigh Onto The Balance Also My Experience Of The Time Management. There Are Continuous Changes Of The Project Development, Issues, Requirement Added At The Last Moment, Unavailability Of Resources. I’m Creative And Able To Manage Time, Resources And Issues At Once Doing My Best To Solve Multiple Tasks Giving Responsibility To The Team Leading Them. Then I Check The Situation And Escalate If Other Resources Are Necessary. Nothing Goes Exactly As You Desired Or Planned. Doing Something Without Blaming Is A Part Of Natural Trait.

Experiences

Technical IVD and Drug Delivery Senior Design and Development Quality Assurance Engineer in a “Medical Devices Design Center”

02-2007 - NowPersonal servicesI'm involved in the Quality Management System implementation and maintenance such as: CAPA, NC (including Clinical Trial Customer Complaints management and resolution), KPI, Supplier Qualification, Data Analysis, QMS and Project Audits, Customer Audit and Notified Body Audits Management, Training on QMS and Project related activities, new employees Tutoring, IQ, OQ and PQ of plastic injection tools and Automated Test Equipment for the manufacturing line etc. My core responsibility is the management of the “IVD (In Vitro Diagnostic) and Pre-Filled Drug Delivery Devices” Design and Development team, including mechanical, electrical, software and tooling engineers. The secondary aim, but not less important is to manage the documentation generated and ensure that everyone follows the QMS and regulatory rules. I'm also responsible to supervise the activities described in the Design and Development plan supporting the project manager throughout the development phases. The Risk Management strategy is under my responsibility. I’m also responsible to coordinate the team generating the dFMEA and all the required risk management documentation. I’ve experience with the GMP during the line assembly in the manufacturing plants. I’ve also experience of small concept production line builds within the design center. I’ve followed directly the build of a small batch of clinical trial medical devices. The batch record has been generated manually without a dedicated manufacturing software. The release has been signed off by the customer. We’ve performed several DOE protocols and reports in order to ensure which parameters could grant a six sigma value for critical values such as dimensions or drop resistance from 1 meter.

Quality Assurance Manager

11-2006 - 02-2007 Energy / Materials / MechanicsI’ve implemented from scratch the QMS (ISO 9001) inside and “Alarm systems manufacturing” company (VIMO Electronics and Unitek). I’ve also supervised the data entry of all the production build work instructions and BOM in the ERP system AS400. My responsibility has been also extended to verify the suppliers, build work instructions and the quality control plans.

Automotive Quality Engineer/Manager. “Automotive Mechanical Components”

01-2003 - 10-2006 Energy / Materials / Mechanics. I helped the GM to develop and put into effect improvement actions, with the purpose to improve the efficiency of company’s resources. My experience encompasses APQP, PPAP, 8D reports, Nonconformities management, Preventive and Improvement Plan (lean manufacturing), coordinate Instruments and Process Equipment calibration/maintenance, batch release, training on QMS to the manufacturing operators, management review support to the General Manager etc.

Education & training

Politecnico di Milano

1999 - 2003 Milan, Italy, MilanProject / Product management

My soft skills

Creative
Persevering
Team player
Enterprising

Languages spoken

  • English

    Native language

  • Italian

    Native language

  • French

    Intermediate

  • German

    Basic

My dreams

One day

Build the piece of the puzzle that will make this world a healthier place to live in.

Make every future a success.
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