Shane Varnadore Email & Phone Number

Standard-Knapp manufactures secondary packaging equipment. Primary packaging puts the product into the retail container. Secondary packaging places the retail containers into cases.• Created, edited, and disseminated system technical manuals using blueprints, engineering drawings, and subject matter experts.• Responsible for all customer-intended technical documentation relating to our systems.• Created all internal procedures and instructions for the position of Technical Writer. • Created training materials for use by service engineers in training customer employees.• Created an all-digital system for monitoring various aspects of the job and ensuring accuracy.• Created and maintained a digital document and image repository.• Also responsible for marketing materials, customer support, travel services, safety labeling, creating training content, and service engineer support. • Created safety labels for industrial equipment using ANSI and OSHA standards.• I did this while processing 25% of all spare parts quotes and orders.

PGS specializes in CNC grinding to high precision tolerances that reach into the micron range. In my role as Quality System Administrator / Technical Writer, I was responsible for all aspects of our quality system.• Drafted, processed, released, and maintained all procedures and instructions.• Created training materials for use by service engineers in training customer employees.• Responsible for our Corrective and Preventive Action (CAPA) system including problem solving, root cause analysis, problem resolution, and follow-up as needed.• Created and monitored our data analysis tools, including Cp, Cpk, and SPC.• Monitored all aspects of our quality system making extensive use of conditionally-formatted Excel spreadsheets. The use of conditional formatting allowed me to see due date status levels in green, yellow, and red, depending on how far from target date.• Created and maintained the entire quality management system (compliant with AS9100 and various other industry requirements). • Responsible for all aspects of quality and regulatory compliance as well as safety, training, and human resources concerns. • Utilized password protection on all fillable documents to prevent accidental alteration.• All work performed using the Microsoft Office suite and Adobe Creative Suite.• Our customers included Pratt & Whitney, Boeing, and various, smaller organizations. Most of these companies are AS9100 compliant and many, like Pratt & Whitney, have their own, rather substantial, requirements.

Wheeling, Il, Us

BBH designs and manufactures high-speed mail and paper processing systems. I worked as a Technical Writer, Illustrator, and Editor.• Created, edited, and disseminated system technical manuals using blueprints, engineering drawings, and subject-matter experts.• Created, edited, and disseminated service bulletins.• Created business process procedures for all areas of the company.• Created and provided training to visiting service personnel.• Created and maintained a copyright/trademark list for all references in our documentation.• Automated editing processes, resulting in 50% savings in time.• Created new manual template, resulting in 25% savings in manual size.

Advanced Image Enhancement (AIE) designs specialized software that enhances digital images for diagnostic imaging. I established their entire quality system. Microsoft Office was used for all documents.Created the entire documentation system including:• Organizational control with complaint handling, internal audits, management review, purchasing, records retention, regulatory inspections, risk management, and the quality system manual.• Design and development control, review, validation, and transfer.• Product and process control, identification, traceability.Quality management system fulfills the requirements of the FDA, ISO, and other regulatory agenciesThe entire quality management system was completed in under 150 pages.https://www.aie-inc.net/

Marlborough, Ma, Us

I was responsible for all phases of Design and Process Validation from creating and reviewing input documents, through design verification and validation, to performing process validation and authoring the final validation report. • Process Validation including Installation, Operation, and Process Qualifications (IQ, OQ, PQ).• Design Verification and Validation (Software and Hardware).• FDA submission support (PMA, 510(k), etc).

Marlborough, Ma, Us

Create, modify, and validate manufacturing documentation. Validate new manufacturing fixtures, repair and re-validate old ones as needed. • Lead auditor to ISO-9001, ISO-13485, and 21CFR part 820 (QSR) standards.• Wrote computer scripts (macros) in WordPerfect to allow for easy data processing within documents.

Marlborough, Ma, Us

Tested, calibrated, troubleshot and repaired analog and digital x-ray mammography systems.• Updated manufacturing documentation.• Administered our New Employee Orientation & Training (NEOT) program.• Created content for and taught portions of the NEOT program.• Created a 55-page, decision-tree troubleshooting system for technicians which saved countless hours of troubleshooting our multi-microprocessor systems.