Kirk Mackin Email & Phone Number

Fort Collins, Colorado, United States

Quality Manager implementing Quality Control and Assurance programs in a hybrid environment of Veterinary Products, Medical Devices and Military Applications. Regulatory manager working with CVM for submission and approval of VMF.

Broomfield, Colorado

Quality and Regulatory Manager for start-up medical device company. Achieved 510(k) approval in August of 2021 while maintaining FDA 21 CFR Regulations and ISO 13485:2016 Standards.-Oversee the Quality & Regulatory function by designing, implementing , maintaining and improving the quality systems and advising the CardioNXT team on Quality & Regulatory standards applicable to the business.-Member of the management team, promoting quality/regulatory awareness and support of business objectives.-Negotiate contracts and coordinate with consultants, suppliers, manufacturers and auditors with business needs and regulatory expectations and requirements.-Support Management team with strategical and tactical business goals -Completion of ISO 13485:2016 Lead Auditor training in January 2019.

Broomfield, Co

Senior Manager of multiple lines of business within Apple Retail. Managed team to achieve daily operational objectives, human resource and hiring needs, inventory management, sales goals and customer service support functions.• Trained and developed retail team in six different departments including Inventory Management, Technical Support, customer education and sales.• Recruited, hired, trained and developed talented Apple team of 101 employees• Market representative directing People Leaders and Human Resource Team in strategic, logistical and human resource changes • Business liaison working with sales team and small businesses for conversion of technology to Apple products• Composed and administered quarterly and annual performance reviews of Apple store team• Addressed customer inquiries and resolved customer complaints and concerns through Apple Service Model• Organized and executed 23 successful Apple product launches including first Apple iPhone in 2007

Broomfield, Colorado, United States

• Denver market manager and mentor for merchandising implementations, retrofits and marketing changes of four Apple Retail stores• Back- of-House Manager overseeing quarterly and yearly inventory audits and management of daily inventory and team of six back of house employees• Processing and shipping / receiving of Apple product through SAP system• Received Ovation Award for highest performing Genius/Tech Support team in the world in 2010• Trained and developed retail team in six different departments including inventory management, technical support, customer education and sales• Coached and developed team to attain daily and yearly sales goals