Dave Redepenning Email & Phone Number

Transitioned to Senior Quality Inspection Manager to ensure Cirtec Medical is in compliance to all Quality Management System (QMS) processes and policies with oversight for all site-level Quality Inspection Groups.✦ Lead and supervise Supervisors, Contract Personnel, Technicians, Specialist, and other Quality personnel.✦ Oversee Incoming (Receiving and Inspection), in-process inspection, final inspection, cleanroom in-process and final inspection, as well as product release support groups.✦ Adhere to occupational safety and health requirements (OSHA), including Personal Protective Equipment (PPE) guidelines and rules.✦ Support and enforce Quality Best Practices and GDP/GMD continuous improvement initiatives.✦ Administer employment practices, including monitoring attendance, counseling, and disciplinary actions for employees as well as related hiring and termination at the discretion of the Site Quality Leader.✦ Monitor metrics in cleanroom to compare total hours worked versus product output.

Brooklyn Park, Mn.

Promoted to Cleanroom Quality Team Manager to supervise a team of quality inspectors and lead the hiring of employees for the department in the area used for assembly of implantable devices.✦ Planned and directed activities to ensure medical components and assemblies meet and exceed customer requirements for the department generating the highest revenue for Cirtec.✦ Drove continuous improvements to processes while meeting production goals.✦ Coached team members to elevate performance to the highest standards and conducted annual performance reviews for staff of 12.

(Stellar Technologies, acquired by Cirtec in 2015) Recruited to set up Stellar Technologies calibration system used in the manufacture of medical components. ✦ Created inspection plans using the prints to allow the inspector to complete inspections.✦ Performed installation qualifications (IQ), process qualifications (PQ), and operational qualifications (OQ) in compliance with regulations.✦ Set up existing calibration using Gage Insight software and calibrated new and existing equipment to traceable standards.✦ Ensured products are carefully planned, reviewed, and revised during development process to comply with Stellar quality requirement.✦ Analyzed all available information to determine when products were not manufactured to customers’ satisfaction and incorporated knowledge into product review and revision process.✦ Successfully passed supplier and regulatory audits, including ISO.