Quality Assurance Medical Device

Paul M. Beaupre

********@*****.***

** ****** ********* *** ****: 339-***-****

Abington, MA 02351 Cell: 508-***-****

MANAGEMENT PROFILE

Over 19 years' Management and Leadership Experience in Manufacturing Operations and Quality

16 years' in Medical Device Industries Managed Team of 40+ Led High Profile Projects to

Successful Results

Accomplished, outcome driven professional with year-over-year success in leading challenging initiatives

with emphasis on manufacturing production, scheduling and control, quality assurance and quality

control, project development, budget management, personnel and employee relations and capital

improvement.

PROFESSIONAL EXPERIENCE

Ranfac Corporation Avon, MA

Single-Source Medical Device Manufacturing Facility

Manufacturing Manager 2005 to Present

Assumed responsibility for the strategic planning, manufacturing management, project development and

production of single use medical devices helping to lead the company to double digit growth for the past 5

consecutive years. Helping to lead the company from 3 million to 10 million in annual sales. Manage 40+

directs and two shifts. Report directly to the Vice President of Operations. Plan and establish daily, weekly

and monthly work schedules, assignments and production sequences to meet production goals as

directed by customers. Recommended and implemented measures to motivate employees and to

improve production methods, equipment performance, product quality and efficiency. Requisitioned

materials, supplies, equipment parts and repair services. Determine standards, budgets, production goals

and rates based on company policies, equipment and labor availability and workloads. Enforce safety and

sanitation regulations. Instrumental in the implementation of instrument stainless steel and plastic

cleaning. Establish operating goals, realignment initiatives, productivity improvements and cost reduction

programs that consistently improve product quality and output. Maintain operations data such as time,

production and cost records and prepared management reports of production results. Interpret

specifications, blueprints, job orders and company policies and procedures for workers. Demonstrate

equipment operations and work and safety procedures to new employees and assigned employees to

experienced workers for training. Restructured and improved the Controlled Environment Room and main

assembly rooms and renovated the final packaging area.

Quality Assurance and Regulatory Manager 2002 to 2005

Brought onboard to lead quality team to the next ISO update to 13485; company is still maintaining this

standard today. Promoted quality achievement and performance improvement throughout the

organization. Maintained awareness of company’s overall performance, including profitability and budget

control. Assessed suppliers, internal product specifications and customer requirements. Worked with

purchasing to establish quality levels for suppliers. Ensured compliance to all company policies and

procedures. Established and improved Quality Assurance Systems and methods. Developed the quality

organization by identifying areas of training needs. Collated, analyzed and reported performance data and

charts quarterly against pre-defined parameters. Supervised quality staff in carrying out tests and checks.

Called upon customers in an effort to promote good will and customer appreciation. Managed quality

assurance internally and maintained MAS-90 audit system for improvement within the company. Analyzed

new processes for stability and capability. Made information available as required to identify problem

areas and drive corrective actions development. Managed internal and external audits plant-wide.

Advised and managed changes to document control system. Communicated regularly with

Manufacturing, Purchasing, Production Control, Maintenance and Administration.

Biolink Corporation Norwell, MA

ISO 9001 privately held medical device company focused on developing solutions for

vascular access

Quality Supervisor 2000 to 2002

Supervised the manufacturing of flexible catheters to coincide with the development of implanted

hemodialysis access port systems. Developed all written quality procedures. Managed 3 direct reports.

Established standards for finished packaged devices. Oversaw all customer complaints and internal and

external non-conformities. Integral in the approval and establishment of approved vendors.

Creative Imprints Norton MA

ISO 9002 privately held medical device company providing transfer pad imprinting services

Quality Assurance Manager and Plant Manager 1996 to 2000

Oversaw all incoming, in-process and final inspections. Verify blueprint specifications for printing

operations. Developed reviewed and implemented quality procedures for ISO 9000 certification.

Established inspection criteria to ship to customer stock. Hired and trained new quality personnel.

Instrumental in the growth of the company requiring a move to and management of a 20,000 sf clean,

environmentally-controlled production facility.

Caton Connector Corporation Kingston MA

High voltage cable and connector company

Quality Control Supervisor 1992 to 1996

Oversaw all incoming, in-process and final inspections. Trained and managed 3 direct reports. Company

liaison to United States Navy. Planned, promoted and organized training activities related to product

quality and reliability. Member of Safety Committee.

United States Air Force

RAF Bentwaters Great Britain, Misawa AFB Japan, Edwards AFB California

Munitions Systems Specialist 1982 to 1992

Supply point monitor accountable for war ready munitions. Shipped and received hazardous munitions.

Inspected, warehoused and transported hazardous cargo. Secret Security Clearance. Played for Armed

Forces traveling baseball team. Honorably Discharged.

EDUCATION AND ACTIVITIES

Associates in Business Administration - USAF 1986

Numerous Air Force Certificates of Training and Achievement and Commendation Medals 1982-1992

Youth Football, Basketball and Baseball Coach 2007- present

References available upon request

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