SUMMARY:

Quality systems, regulatory compliance, international harmonization, gap analysis, complaints, root cause analysis, product testing, auditing, compliance analysis, presentations, training, & technical writing

PROFESSIONAL EXPERIENCE:

Technical Writer

Confidential, Dallas, Texas

Responsibilities:

• Developed white paper on background information for new product for use in integrated operating rooms
• Developed white paper on MDSAP (Medical Device Single Audit Program)
• Developed white paper on Confidential Requirements
• Revised Use Case, Functional Description, and Product Requirements documents

Technical Writer & Quality

Confidential, Groton, CT

Responsibilities:

• Developed white paper for second phase of a new manufacturing process being implemented (part - time remote work)

Regulatory Affairs Technical Writer

Confidential, Raynham, MA

Responsibilities:

• Updating and improving IFUs (Information for Use) for Confidential
• Creating template for maintenance and troubleshooting manuals for Confidential
• Revising maintenance and troubleshooting manuals for Confidential
• Documenting technical writing procedures relevant to Regulatory Affairs

Technical Writer & Quality

Confidential, Groton, CT

Responsibilities:

• QA assessment and recommendations for SOP regulatory compliance and improvements
• Technical writing (development), review, and revision of white papers, sections for regulatory submissions, and publications
• Technical writing “Best Practices” for Confidential - website improvements
• Member and editor - Communications Teams - articles, interviews, Communications Team manual
• Gap analyses of QA SOPs against Confidential requirements, 21 CFR 820.30, Design Controls, and data verification

Quality Engineer/Developer/Technical Writer

Confidential, Brimfield, MA

Responsibilities:

• Orthopaedic Confidential & instruments
• Team member for Confidential audit readiness and compliance
• Responsible for writing IQ/OQ/PQ validations for facility’s Confidential welding, ultrasonic cleaning lines, manual lathes, and manual grinder to comply with DePuy medical device requirements
• Created various safety manuals, preventive maintenance and troubleshooting manuals, SOPs/work instructions, and forms
• Developed & taught training PowerPoint for ultrasonic cleaning

Supplier Quality Engineer

Confidential, Raynham, MA

Responsibilities:

• Supplier quality engineering for orthopaedic Confidential
• Compliance reviews of supplier documentation
• Document management of process verification activities for Agile
• Development of product inspection criteria (PIC) incoming inspection worksheets

QA Consultant & Developer/Technical Writer

Confidential, Raynham, MA

Responsibilities:

• Tasked by Confidential ’s Design Engineering Director to perform gap analyses and Confidential of Confidential ’s Design Engineering Department to determine opportunities for improvement - made recommendation to change name of department which was implemented
• Performed gap analyses and Confidential for Confidential ’s case-and-tray development process done in conjunction with outside supplier manufacturer - developed cross-department function SOP in response
• Created process step diagrams to document Design Engineering Department’s workflows
• Worked with SMEs to develop Work Instructions (SOP) and flowcharted multi-department Case-and-Tray Development Process
• Developed and revised numerous other Work Instructions/SOPs
• Member of the Engineering Technology Team

Developer/Technical Writer

Confidential, Waltham, MA

Responsibilities:

• Taught on-site and hand-groomed by Confidential editors
• Developed integrated SOPs in response to a decree sanction for pharmaceutical manufacturer, Confidential
• Recommended revising approaches to develop integrated SOPs to ensure quality and for regulatory compliance in manufacturing environment, approved by pharmaceutical manufacturer, and adopted for all project developers

Supplier Quality Engineer

Confidential, Orangeburg, NY

Responsibilities:

• Responsible for Material Approval Program (MAP) for new supplier contracts and engineering work orders including revising procedures, forms, and transferring information requirements to purchasing phase
• Developed Lab shade matching program
• Developed calibration and process control program for suppliers
• Developed Confidential instructions for off-shore manufacturers

Technical Writer

Confidential, Golden, CO

Responsibilities:

• Worked with IT development team to create work instructions for new QMS reporting system
• Developed template for work instructions for Confidential ’s QMS reporting system
• Developed work instructions for various elements of the QMS reporting system, e.g., creating a new document (both with and without a template,) creating a new drawing, creating a new NCR, creating a new skill, inactivating an employee, revising a document, creating a record, submitting a change request etc.

Quality & Standards Senior Analyst

Confidential

Responsibilities:

• Improved operational efficiency of Providence Confidential ’s in-house processes, including harmonizing with Confidential ’s and corporate Confidential ’s policies and requirements, by performing gap analyses, clarifying, flowcharting, and developing documented SOPs
• Established SOP format & SOP doc control system for Providence using FS Pro ( Confidential )
• Senior HIPAA investigator - 9 months - spearheaded root cause analyses and Confidential for HIPAA violations
• Confidential investigator on various issues as they arose
• Critiqued efficacy of Lean Six Sigma Yellow Belt training held onsite on July 2-3, 2012; wrote supplemental white paper entitled, The Truth about Six Sigma focusing on accurate and inaccurate applications of Six Sigma
• Developed five (5) Purchasing SOPs deemed “best practices” by corporate Confidential purchasing group

Quality Process Engineer

Confidential, Fall River, MA

Responsibilities:

• QS 9000 coordinator for Fall River - company rep for automotive and upholstery outside auditors
• Responsible for PPAPs and FMEAs for automotive upholstery - company representative for third-party quality and compliance inspections
• Developed, wrote, and implemented systems for ISO 9001 and the upholstered office furniture

Director of Quality Assurance & Consumer Safety

Confidential, Jersey City, NJ

Responsibilities:

• TMA committee member for revising ASTM F963, Confidential Safety standard
• Responsible for ensuring design and engineering departments met toy safety requirements for consumer use and ensured Eden’s overall compliance with ASTM F-963 and other worldwide toy safety requirements
• Handled all consumer complaints - liaised with TMA attorney and Confidential CEO regarding sensitive complaint issues
• Directed all Confidential investigations related to consumer complaints
• Managed $750,000 department budget
• Tasked by CEO to determine failure of off-shore quality inspection manual - conducted Confidential and revised manual using statistical sampling for part & product testing, assembly validations, & visual inspections, which was praised by Confidential ’ Confidential distributor and adopted for its use
• Performed on-site qualifications of off-shore manufacturers and potential suppliers
• Directed overseas quality assurance and Eden inspection teams for manufacturers located in China, Haiti, Hong Kong, Korea, the Philippines, Taiwan, and Thailand - Frequent travel to off-shore manufacturing plants
• Proofed all bills of materials and work instructions prior to sending to off-shore manufactures
• Developed system for aesthetic standards and requirements transfers to off-shore manufacturers and Eden’s inspection teams
• Collaborated with engineering to evaluated potential suppliers for manufacturing suitability
• Collaborated with design development teams on concepts and design development
• Approved suppliers on parts assembly & manufacturing methods - testing and validation acceptance for safety & assembly

Director of Quality Assurance

Confidential, Fall River, MA

Responsibilities:

• Responsible for Defense contract compliance with quality, safety, and inspection requirements for procedures, test records, and auditing
• Frequent interfacing with Confidential agencies & contractors - company liaison for Defense agencies and inspections
• Responsible for QA systems at three manufacturing plants - oversaw all root cause analyses
• Initiated & spearheaded Confidential investigation that overturned a $7 million Defense rejection that involved Defense Personnel Support Center’s quality laboratory and the Aberdeen Proving Grounds in Maryland - spent three weeks at Confidential ’s laboratories as part of root cause investigation
• Made numerous recommendations to improve Confidential textile specifications and test methods that were accepted by the Confidential
• Oversaw three testing laboratories - achieved inclusion on Defense Personnel Supply Center’s Qualified Laboratory List (QLL)
• Established calibration program in compliance with Mil-Std-45662
• Developed and implemented document control system
• Created and taught only Confidential technician training program for Defense textile specifications and test methods

Quality Assurance Representative

Confidential, Boston

Responsibilities:

• Top Secret clearance - (currently inactive)
• Ensured Confidential ’s quality and testing requirements were carried out at Defense contractors through auditing and inspections
• Trained to identify and report Defense contractor fraud
• Selected for pilot Lab color-matching training
• Confidential certified in clothing and textiles
• Performed First Article inspections