Kirk Mackin Email and Phone Number
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Quality and Regulatory Manager, overseeing regulated environments for Medical Devices, Veterinary Products, Military and Defense systems and General Manufacturing.
Mantel Technologies
View- Website:
- manteltechnologies.com
- Employees:
- 12
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Quality ManagerMantel Technologies Mar 2022 - PresentFort Collins, Colorado, United StatesQuality 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.
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Quality And Regulatory ManagerCardionxt, Inc. Mar 2014 - Mar 2022Broomfield, ColoradoQuality 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. -
Senior Manager - People Leader And Customer ExperienceApple Oct 2011 - Sep 2013Broomfield, CoSenior 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 -
Store ManagerApple Mar 2007 - Oct 2011Broomfield, 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
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ManagerBose Corporation Jun 1998 - Oct 2006
Kirk Mackin Skills
Kirk Mackin Education Details
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Hotel, Motel, And Restaurant Management
Frequently Asked Questions about Kirk Mackin
What company does Kirk Mackin work for?
Kirk Mackin works for Mantel Technologies
What is Kirk Mackin's role at the current company?
Kirk Mackin's current role is Quality Manager - Regulatory Consulting with focus on veterinary blood products, GMP requirements and ISO-13485..
What is Kirk Mackin's email address?
Kirk Mackin's email address is ki****@****nxt.com
What schools did Kirk Mackin attend?
Kirk Mackin attended Colorado State University.
What skills is Kirk Mackin known for?
Kirk Mackin has skills like Medical Devices, Quality Management, Regulatory Affairs, Quality System, Business Development, Business Strategy, Clinical Trials, Quality Control, Due Diligence, U.s. Food And Drug Administration, Iso 13485, Retail.
Who are Kirk Mackin's colleagues?
Kirk Mackin's colleagues are Meghan Haselden, Robert Buntz, Jessica Gilliam, Kiran Badola, Elam Curry, Alex Inman, Adrian Felts, Pmp, Fmp, Isp.
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