SHIRAJUL KARIM- Resume
- 1. SHIRAJUL KARIM 3260 Coastal Oak Dr. Simi Valley, California 93065 Home Phone: (805) 581-3758 TKarim@SBCglobal.net CAREER SUMMARY: Proven track record of delivering multiple projects simultaneously within budget and on schedule. Managed more than one hundred employees in various industries including aerospace, commercial electronic, orthopedics (implantable and disposables) and diabetes industries. • Manage projects such as, Product Qualification, Design and Process FMEA, Process Validation, Risk Analysis and Product Quality Plans. • Manage Quality Improvement Teams; (CAPA) which consist of continues improvement for various product lines, field returns, supplier corrective action, internal audits and Lean, Six Sigma projects. • Departmental Budget, Schedule and Cost Control for over one hundred employees. • Organizational Strategic Planning for Quality Engineering, Reliability, Design Assurance, Failure Analysis departments and Software Quality. • Product Reliability Testing to comply with all standards for External Implantable and Disposable products. (IEC, ISTA, GMP, etc.) • Submitted several 510k and involved in multiple PMA submissions. • Successfully lead multiple FDA, ISO and DOD audits. • Actively participated in design and process problem solving including change control • Drove Lean, Six Sigma implementation throughout the company • Implemented ISO13485, 2003. EMPLOYMENT EXPERIENCE: 01/11 TO PRESENT – MEDTRONIC MINIMED, NORTHRIDGE, CA. VICE PRESIDENT OF QUALITY Manages Quality Engineering, Reliability, Design Assurance, Software Quality, Document Control, Internal Audit, Supplier Quality and Quality Systems groups consist of over 110 employees and 5 Million dollars of budget. Develops quality strategy and implements programs, which results in the highest quality products and services for our customers. Manages the development of core quality standards across Diabetes for product development. Develops organizational capabilities and successors for Quality positions. Assesses current skill and knowledge levels, identifies gaps and provides appropriate training/development plans. Responsible for leading all quality activities and assuring compliance with all applicable
- 2. regulatory requirements. Provides on-going performance feedback and career coaching, and when needed, corrective action to ensure high performance for the Quality staff. Serves as a member of the Senior Leadership team as well as the Management Representative for the organization’s Quality Management System. Represents Medtronic Diabetes on Medtronic’s Corporate Quality Council. Provides leadership and support for Medtronic enterprise wide quality initiatives. 04/94 TO 1/11 – MEDTRONIC MINIMED, NORTHRIDGE, CA. SR. DIRECTOR OF QUALITY ASSURANCE & QUALITY CONTROL Create project plans for new and existing products with Research, Development and Engineering, and Product Support Engineering. Developed a sound Quality and Reliability and Software Quality engineering structure for the performance of all phases of the Quality and Reliability engineering activities such as MRB, QIT, CCB, Design Review, Design FMEA, Process FMEA, Equipment and Process Validation, Risk Analysis, Essential Requirement Matrix, performing Design Verification Test, Qualifying products, (Hardware & Software) per FDA and Internal standards, and solving design and production problems. Keeps the staff informed about department objectives, company policies, plans, new projects and provides technical leadership. Participates as a reviewer of the Design Control Process for new or existing projects. Review and Validate design changes. Solve product, component and field problems as the Quality Improvement Team chairman. Review and determine quality and inspection requirements on all drawings. Involved with sterilization validation and capacity issues. Perform FMEA for design and process. Create Test protocol for new design & components according to all standards, such as IEC, ISTA, etc. Plan Reliable testing for new projects and significant design changes. Participate in reviewing 510k and PMA and Lean, Six Sigma implementation throughout the company. 04/91 to 04/94 – MICROAIRE SURGICAL INSTRUMENT, VALENCIA, CA. DIRECTOR OF QUALITY & REGULATORY AFFAIRS. Managed Quality Assurance and Regulatory compliance department consist of Inspection, Quality Engineering and Regulatory Affairs. Revised and implemented GMP procedures throughout the company. Implemented product failure analysis, internal and external corrective actions, Packaging integrity test, sterilization validation process, vendor audit, MDR reporting, clinical test for new products. Personally involved with FDA’s company audit. Submitted all 501K approvals for the company. Obtained all products export approval through FDA. Review and approve design documentation. Created Acceptance Test Procedures for new products. Developed a training program in Total Quality Control for different levels and functions. Familiar with MIL-STANDARDS, capable of operating PC base application software such as; Microsoft Word, Microsoft Excel, Word Star, SPC software. Submitted several 510k while working with Microaire 08/86 TO 04/91 TERMINAL DATA CORPORATION (TDC) MOORPARK, CA. QUALITY ASSURANCE SR. ENGINEER Performed Quality Engineering functions for design, construction and delivery of product for mechanical and electromechanical system. Responsible for product follow through from design development to final design, manufacturing, and assembly. Position involved extensive interface with group i.e R&D and production. Responsibilities included: Participation in design reviews during design and development, participation in Material Review Boards, Management of quality Assurance function for design and development of microfilms and digital scanners, vendor survey
- 3. and selection, Development of a formal Q.A. plan for receiving inspection including determination of critical dimensions, equipment required and inspection levels, development of vendor quality rating system and acted as a technical consultant for existing product. Introduced J.I.T and TQC system in production. 07/84 TO 08/86 J & M PRODUCT, BURBANK, CA (NORTEK DIV) QUALITY ASSURANCE MANAGER: Interprets and applies engineering drawing. Determine tooling for production, analyzes method of production, sequence of operation, work simplification; reduce production time and material cost. Applies time standard data to measure and evaluate production labor time, cost and assembly operation efficiency. Write Quality operation procedure. Recommends and justifies the design and acquisition of capitol equipment, tooling, jigs, fixtures, etc. as required. Help product design by utilizing companies manufacturing capabilities. Solves in process production problems. Deals with vendor quality. Chairman of Material Review Board. Supervise Quality and Manufacturing department. Wrote Quality Manual for company. Established Statistical Process Control, Vendor survey, Calibration of tools, Corrective actions, according to MIL-Q-9858, MIL-I-45208. 01/82 TO 07/84 TERMINAL DATA CORPORATION, WOODLAND HILLS, CA QUALITY ASSURANCE SUPERVISOR: Inspection, critical inspection, and test instruction. Coordinated with Purchasing, Production Control and Operation Departments. Monitored vendor quality and source inspection. Wrote Engineering Change Request. Acted as chairman of Material Review Board. Determine mean time before failure of each unit. In change of burn-in. Monitored vendor service, source inspection, sheet material manufacturing, etc. Organized, conducted and interpreted time and work simplification studies and analysis of production operation to ascertain degree of performance and to effect the most efficient utilization of manpower, material and equipment. EDUCATION: WHARTON EXECUTIVE EDUCATION – UNIVERSITY OF PENNSYLVANIA - 2009 NORTHROP UNIVERSITY, INGLEWOOD, CALIFORNIA. MAJOR: Engineering (Mechanical) DEGREE: B.S. – 1982 NORTHROP UNIVERSITY, INGLEWOOD, CALIFORNIA. MAJOR: Airframe and Power plant Technology DEGREE: A.S. – 1979 NATIONAL TECHNICAL SCHOOL, LOS ANGELES, CALIFORNIA. MAJOR: Automotive and Diesel Engine Technology DEGREE: A.S. – 1977
- 4. PROFESSIONAL TRAINING: • Statistical Process Control • Just In Time and Total Quality Control • FDA Gmp Training • Corporate Management Training • Lean, Six Sigma PROFESSIONAL ASSOCIATION: • Member of ASQC • Member of SME • Member of SAE PROFESSIONAL PROFILE: • Effective leader with strong communication, presentation and team building skills. • Self-motivated professional with over twenty years of experience in organizational and management experience including project management. • Adept at applying logical but creative approaches to problem solving. • Good technical (design and process) skills. • Experience in personal computers (MS Office, etc.)