Manager Quality

Location:

Somerset, MA, 02724

Posted:

July 09, 2012

Contact this candidate

Resume:

SUSAN F. RAPOZA

** ****** **.

Fall River, Ma. **724

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

Home: 508-***-****

Cell: 508-***-****

Summary

Senior manager with twenty one years of experience in the Medical Device industry and full knowledge of ISO 13485, 21CFR 820, and GMP Guidelines. A demonstrated leader who excels at maintaining team organization and motivation with the ability to adapt and overcome issues with ease while managing multiple projects. Detail oriented and focused on upholding a commitment to quality and customer satisfaction.

Employment History

2004 – 2012 Millstone Medical Outsourcing

Jan. 2009 – 2012 Program Manager

As Program Manager (PM) at Millstone I acted as the primary contact for the client, providing them with an understanding of the entire Millstone Quality System and Operational processes, as well as providing Millstone with all client specific requirements and expectations. I was also responsible for coordination of product launches and management of the business going forward.

Managed activity for multiple clients specializing in several of the major orthopedic companies in the industry with extensive or complex validation requirements

Ensured the highest level of Quality and Customer satisfaction

Responsible for customer contracts with yearly review and revisions

Coordinated completion of necessary validation activities with the Engineering team upon introduction of each new client such as packaging, sealing, sterilization validations utilizing Microsoft Project to establish timelines to meet designated milestones

Coordinated the completion of necessary work instructions, drawings, labeling and other documents relative to introduction of new clients utilizing Microsoft Project

Managed initial program launch with Operations to confirm expectations and requirements

Responsible for obtaining monthly/yearly forecast information for each client and working with operations to ensure adequate resources for the program

Managed revenue budgets to actual deviations

Maintained open communication with each client by establishing weekly conference calls and updating the internal teams; Executive, Quality, Sales, Finance and Ops with open issues as necessary

Ensured client satisfaction of product lead time through the packaging and sterilization process

Assessed and incorporated new client requirements

Worked with operations on an ongoing basis to develop streamlined processes and gained client approval to implement those improvements

Jan. 2008 – Jan. 2009 Director of Quality Engineering

Assembled and managed the Quality Engineering team to ensure implementation of new client introductions and product launches with the highest level of Quality and Customer satisfaction.

Primary contact for customer validation activities

Created and maintained project timelines to coordinate satisfactory completeness of project launch activities

Review and approval of IQ, OQ, PQ protocols and reports as well as PFMEA Analysis

Led engineering team to ensure completion of necessary validation activities (IQ, OQ, PQ) including packaging, sealing, cleaning and sterilization validations with introduction of new clients

Ensured completion and accuracy of necessary work instructions/documents and labeling relative to introduction of new clients

Oversight of initial program launch with Operations to confirm expectations and requirements – process validation

Achieved business goals working with cross functional teams and staff

2006- 2008 Director of Quality

Quality Management Representative for ISO 13485 and FDA regulated audits and activities. Company representative responsible for the audits performed routinely by new/existing clientele. Implemented changes to the quality system in response to audit reports as necessary.

Responsible for the Document Control System and personnel, approval of ECR activities.

Review and approval of IQ, OQ, PQ protocols, reports, documentation and labeling

Responsible for the activities of the Quality Engineering Team;

IQ, OQ, PQ writing and execution of various validations, including sterile packaging and sterilization validations required to integrate new client specific needs into the company quality system.

Drafting the written client specific procedures for production and for product label design.

Responsible for the Quality Management System, maintained compliance with ISO 13485, FDA 21CFR 820, and standard GMP regulations.

Addressed Customer Complaints, successfully managing a client recall and rework situation

Maintained NCMR and Corrective Action processes (CAPA), addressing non conformances and continuous improvement

Responsible for incoming receiving inspection, mechanical inspection, in process inspection activities, document control, coordination of sterilization activities and product release.

2004-2006 Quality Process Engineer

Responsible for new client integration into the company’s outsourcing activities

Writing and executing various customer specific validation activities (IQ, OQ, PQ) such as ultrasonic cleaning, pouch/tray sealing, ship testing, aging studies and sterilization validation.

Writing closing reports and obtaining client and Millstone internal approval

Also responsible for the creation of client specifications.

Label Designer – Design client specific sterile and non-sterile packaging labeling.

Responsible for the technical aspects of the Label Printing System

1991-2004 Teleflex Medical (Formerly Genzyme Biosurgery), Fall River, Ma

2000 Engineering Support Team Leader/Mfg. Engineering Systems Specialist

Supervisor of Engineering Support Coordinators, responsible for project management, Team performance, training, and evaluations.

Responsible for all Engineering Change Orders, creating and /or revising procedures, drawings, Bill of Materials and routers utilized in the production area, ensuring correct usage on the production floor.

The Certified Lead Trainer responsible for training production Trainers and Team Leaders.

Team Member for ISO 9001/EN 46001 Certification, with certification and experience as an Internal Auditor.

Member of the Internal Auditing System and ISO Certification.

Bar Code Scanning System Administrator.

1998 Manufacturing Systems Specialist

Became a member of the new product launch groups and responsible for all documentation associated with new product launches.

Bar Code Scanning System Administrator responsible for maintaining, troubleshooting and upgrading the system when necessary.

Experience in Access database programming. Established databases for Equipment Identification, Preventive Maintenance scheduling and tracking, Project Management and for Documentation rev control.

Responsible for implementing and maintaining a new documentation training program within the department to meet ISO & GMP Guideline.

Coordinated and established a new Kitting area in a “Clean Room” environment.

Responsible for creating and maintaining a Document Rev Control system in the production area.

Provided continued technical support for the label printing processes.

1991-1995 Documentation / Validation Coordinator

Responsible for review of procedures for clarity and accuracy. Revised as necessary.

Responsible for creating and maintaining the Equipment and Process Validation Access Databases for the Engineering Department.

Responsible for development and launch of new CE Marked product for European market.

Production Bar Code Scanning System Implementation team Member.

Became a product labeling designer and implemented in-house label printing within the department.

Software Skills

Microsoft Project, Microsoft Access, Excel, Word, Power Point, Novell, Various Labeling Systems Software and Business Inventory Management Systems.