Medical Device Supervisor

**** ******** *** 510-***-****

Hayward, CA, ***45 ************@***.***

Objective: Seeking a position as a production supervisor in a team oriented company

Highlights

• Eighteen years supervisory experience working in medical device companies with consistently increasing responsibilities in program development, implementation and developing strategies to attain continuous improvement in manufacturing.

• Strong management experience in a controlled cGMP, SOP, FDA and OSHA regulated environment.( ISO 13485 and CFR8200)

• Highly effective in analyzing workflow using Lean Manufacturing and 5S Principles.

• Strong interpersonal skills, organizational skills and communication skills.

Education

BA, University of the South Pacific, Fiji Islands

Operational Excellence (Lean Leader) South Carolina

Demand Flow Technology, San Jose

CPIM, Sunnyvale

Managing within Law

QSR Training (FDA/ISO Quality System Regulation for medical device)

Multiple Seminars and Career Development Classes.

Work History

Covidien/VNUS

San Jose, CA

Focus Factory Manager-Interim June 2010 to December 2010

Senior Production Supervisor May 2007 to June 2010

Supervised exempt and non-exempt manufacturing personnel for manufacturing of various products( Production supervisors, engineers, technicians, buyer/ planners, Assemblers) in providing the necessary guidance and direction; developing staffing plans and setting staff performance objectives

Identified, notified and escalated risk and issues that affected project timeliness, milestones, resource requirements and finance to management. Reported constraints, variance and trends.

Managed and reported financial performance (Key Performance Indicators) to management

Managed and drove continuous improvement and 5S principles (Generated savings of $450,000.00)

Developed work schedules for department by assessing priorities, workload and available resources.

Maintained and reported progress regarding Focus Factory goals on safety (Total Incident Report), quality, service, financial and operational excellence. (Productivity, first pass yield, Total Incident report, Quality Improvement Program, Overall Equipment Effectiveness and UPPD).

Supervised transition of pilot lines into manufacturing, SJ manufacturing to Costa Rica

Increased Units per person per day from 3.9 to 10.5 and yield from 89% to 98.7%

Interview, train, review and discipline when necessary all team members, utilizing existing corporate guidelines and methods. Submit and approve quarterly and focal reviews

Work to develop, nurture and maintain a culture of integrity, appreciation, respect and continual improvement within the operations

Monitor compliance to company policies and procedures (e.g. compliance with FDA GMP/QSR,)

Conduct team member training. Coach, lead and develop team members.

Help investigate customer complaints and implement corrective actions

Lead/Participate in MRB, Quality meeting, Focus Factory meetings, skip level meeting

Assess manpower needs and develop capacity plans. Review future manufacturing needs

Review and approve ECO and CAPA, invoices and PO’s

Provide input on manufacturability, ergonomics and capacity plans.

Update and revise Manufacturing Process Instructions/SOP’s,GMP’s, DOP’s to ensure its complete and accurate

Self Employed (Real Estate Agent) June 2006- May 2007

Tactx Medical/Produxx, Inc March 2005 to May 2006

Senior Production Supervisor

Hired and managed team of 30 employees to meet scale up demand of the business.

Train, implement and enforce 5S Principles and Lean manufacturing. Conduct Kaizen meetings.

Lead the effort to review and develop GMP documentation

Write and present operational reports with supplementary graphical and presentational exhibits.

Develop and implement performance measurement and internal auditing FDA type programs in order to routinely evaluate operation efficiency and quality

Help investigate customer complaints and implement corrective actions

Develops work schedules for department by assessing priorities, workload and available resources to meet demanding goals. .

Provide expertise and assistance to support qualification, clinical and validation builds. Facilitate transition of products from R & D to GMP operations

Partner and coordinate with Quality, Team Member Relations, Maintenance, Engineering, and other external departments to resolve issues and concerns.

Boston Scientific OCT 2002 to Feb 2005

Fremont, CA

Senior Production Supervisor (Catheters)

Manage a team of sixty employees and multiple product lines associated with GMP production.

Communicate departmental goals to achieve effective core 5 metric performances.

Help drive, train and implement 5S Principles and Lean manufacturing: increased floor space by 20 %, increased productivity by 25%, and yield by 5%.

Conduct Kaizen and grapevine meetings

Hire, train and evaluate employee’s job performance with emphasis on progressive development.

Manage cross training of personnel in process and implement flexibility measure and metrics

Enforce strict adherence to cGMP, QSR, SOP and Safety procedures. Address ergonomic issues.

Provide guidance and troubleshooting assistance as needed during a deviation in the process

Promote maintenance of safe, accident free environment.

Review SPC data

Percusurge, Medtronic Feb 2001 to July 2002

Sunnyvale, CA

Senior Production Supervisor-Catheters

Guidant June 1992- February 2001

Palo Alto, CA

Assembler: Lead: Senior Production Supervisor

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