Kevin Bach Email & Phone Number

Saint Paul, Mn, Us

Boulder, Colorado, Us

Tensentric is a leader in contract Design R&D and Manufacturing for developing medical devices, in vitro diagnostic systems, and gene and cell therapy solutions.. In my role, I will be leading the Human Factors/UX, Test Engineering and Bio/Chem disciplines while continuing to provide excellent partnerships and engineering work to clients looking to obtain their company's goals

Marlborough, Ma, Us

Minneapolis, Mn, Us

More to come.....

Following FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards I• Participate in product development cycle by reviewing software project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.• Work cross-functionally to implement improvements to the software life cycle, including the establishment of risk management as an integral part of the quality management system as an overall framework for the application of appropriate software engineering methods and techniques.• Create and revise Standard Operating Procedures (SOPs) to support the Quality System in regards to software and system design.• Identify and implement software process metrics for the software product development life cycle. Develop, analyze and monitor metrics pertaining to software defects uncovered during development, testing and post-release.• Recommend and lead corrective and preventive actions to improve software product quality. Ensure documentation and findings are completed on time and in a timely manner in accordance with regulatory agency standards and procedures.• Provide solutions to a wide range of difficult challenges. Determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.• Provide QA oversight to assigned suppliers. Disposition nonconforming product at the Material Review Board meetings. Interface as necessary with suppliers to ensure product specifications are met. Lead supplier audits and assessments.• Promote continuous improvement through the use of such tools as Lean, Six Sigma and Kaizen.• Follow all Quality System Practices as defined by Medtronic Navigation’s practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met.

Chicago, Illinois, Us

Official - grade 6

Marlborough, Ma, Us

Technical Lead for $6.5MM global software project (EMC Documentum). Supervised and responsible for 5 off-site developers, 1 on-site developer and 2 support employees. PM for 3 technical work streams, multiple integrations (SAP), trainings. Conflict resolution, project metric reporting, PM for technical aspects planning through stabilizationTechnical and Team Lead for AssurX's CATSWeb software with 3 total team membersIncorporated Steering Committee with senior management to align business and IS expectations, conflict resolution, provide support metricsLed several software upgrades following IS software and quality system validation protocolOwned and updated support, disaster recovery and FDA inspired software validation documentationPreformed software customer support at a high levelSQA for small/medium projectsProvided Sr level Business Analyst/Software Architect skills to get customers software solution to meet their needsProject manager for several small/medium projects outside main commitments

Collegiate Soccer OfficialElected to participate in post-season officiating

- Use PMI project mgmt procedures for all projects- Performed Business Analyst duties such as gathering business and functional requirements, writing Quality Sytstem documentation, test cases, IQ, OQ, PQ, etc- Leading a group of tech/business associates in implementation of divisional complaint handling software (AssurX). Assist in creation, writing, implementing of IT and business procedures, validation and quality system documentation. - Maintainence and support of Product Surveillance Group (Complaints) software and data. Intimate customer contact and support.- writing of SQA NOCs, test cases, requirements - Excellent knowledge of quality system mandated by the FDA. - Appointed to IT’s interview team for 6 of last 7 positions.- Creation/support of VB.NET, VB6, Access97,PowerBuilder, ColdFustion applications for Sales, Mfg, Complaints, and Legal depts. using SQL Server 2000 or Oracle - Good knowledge of FDA regs for SQA and Complaint Handling. (21 CFR Part 11, etc)

Collegiate soccer official for the state of Arizona

Flagstaff, Arizona, Us

- Develop .NET platform and web applications for students worldwide with ASP.NET and JavaScript. Oracle 9i and Access XP, taught IT team- SQL Server 200 and Access XP database development, installation, and maintenance- Assist Support Systems Analyst Sr. with 130 node XP environment, employee and student technology issues, rebuild/maintain user machines- Employee support and troubleshooting- Introduced to Macromedia Flash- Build, design, and implement IIS web server, maintaince, taught IT team- Windows 2003 server installation and maintenance (minimal)

- Designed, presented, developed, and deployed windows and web applications across company of 100 with development team (VB6, VB.NET, ASP.NET, SQL Server 2000)- Organize development workshop – code review, expose standards, and idea and question sharing- Administration and development of applications, components, and services using .NET suite, VB6, and SQL 2000 languages- write SQL Server 2000 database scripts (functions, procedures, etc)- Designed and developed data processing system for United Kingdom - Production support including troubleshooting application issues, server maintenance, application, processes, and efficency of components

B.S.B.A, Computer Information Systems

Computer Information Systems. B.S.B.A, Computer Information Systems

Environmental Biology