Manager of QA Resume

Profile in Quality Assurance and Regulatory Affairs

MBA degree with emphasis in Industrial Management and 13 years of direct involvement with Quality Systems, Standards, Quality Assurance and Regulatory Affairs in the Medical Device industry with a track record of implementing improvements.Ability to design, develop and implement effective Quality Systems. Prepared for and hosted external and internal audits, owned CAPA program, monitored Complaint records, acted as Management Representative for Quality (MRQ) at Management Reviews.

Strengths

Technical writing, change control (ECOs), labeling, and product configuration. Thorough understanding of regulations, standards, directives (ISO13485:2003, 21CFR820, 93/42/EEC, GMP). Advanced ability in oral and written communication at all levels with excellent spelling, grammar, research, and presentation skills. High level accuracy and detail orientation. Expert in both manual and electronic change control. Development of policies, SOPs, protocols, and final validation reports using client’s templates. All quality documentation and change control for SDLC.

Technical Skills

Advanced Word, Excel, Power Point, Project, Visio, Outlook, Adobe Acrobat Professional, ERP systems, electronic records, 21CFR820 Part 11 compliant documentation systems, JDE, Sperry, SharePoint, PDM, Documentum, MAS200, Master Control, Agile.

Employment History

Technical Writer - on contractat Confidential – Irvine, CA Nov. and Dec 2011

Migrated quality documentation and product information from Master Control to new ERP (QAD). Working with BOMs, routers, SOPs, etc.

Manager of RA/QA, Confidential – Irvine, CA Aug 2010 to Oct 2011

Establishment, maintenance, and execution of the Quality System
Organization, planning and execution of Management Reviews (Management Representative)
Organization, maintenance, issuance, and close-out of CAPAs and CAPA Log maintenance
All Document Control & archiving; procedure writing, labeling, ECRs, master list, etc.
Complaint tracking, resolution & trending
Internal Audits, ISO Audit and FDA Inspection
Foreign registrations
Calibration, Validation, protocols, and drawing approvals
Design History File (DHF), Device Master Record (DMR) and Device History Record (DHR

Assoc Regulatory Specialist, Medtronic – Confidential, CADec 2009 – July 2010 (Contract)

International registrations and submissions at Medtronic in Irvine (Heart Valves).
Obtained apostilles; updated and maintained Declarations of Conformity; obtained Certificates to Foreign Government and Certificates of Free Sale
Updated Essential Requirements Matrices, Technical Files. Provided required documentation to foreign geographies for registration.

Technical Writer, Boston Scientific – Confidential, Rhode IslandOct 2009 – Nov 2009

Short term contract through Validant Consulting, onsite at Boston Scientific
Created and edited documents to the templates and formats used by Boston Scientific after their acquisition of Steris Corp at site in Coventry, RI

Documentation Manager/QA Specialist –Confidential, Fountain Vly, CA Jan 2007 – May 2009

Created the Document Control system including, revision level, ECR, master list, DMR, DHR, etc. Created and implemented the ECO form and the method for approval and signature requirements.
Performed gap analysis for quality system procedures needed to comply with ISO 13485 & FDA. Then wrote or rewrote quality procedures (SOPs) and Work Instructions (WI) to support applicable elements of the Quality Manual.
Assisted the V.P. of RA/QA during FDA and supplier audits, including notified body biennial 2-day review audit.

Project Administrator - Edwards Lifesciences, Confidential, CA Sept 1999 to Nov 2006

Dual role as Documentation Manager for sustaining engineering (heart valves) and Project Administrator for new product development.
7+ years experience in Documentation Control and Product Configuration, Bills of Material
Chaired project team meetings and maintained charters, drove milestone completion, issued agendas and minutes.
Awarded for creating “lean” text in production routers and cleaned up all wordy process sheets for sustaining engineering department to provide concise and clear steps for production operators.

Education

MBA – Industrial Management.
B.S. – Management.

We provide IT Staff Augmentation Services!

We'd love your feedback!

Resume Categories

Client Services

Job Seekers

Visa Sponsorship