Amy P. is a Director of RA and QA at RevMedx. Colleagues describe her as "As Director of the Design Controls group, within Care Innovations, it was my pleasure to hire Amy Pointer, as part of the document control team. Amy was an invaluable member from the start, quickly mastering the systems and processes for document control, while simultaneously identifying areas of improvement. Amy had a terrific willingness to step in, as exemplified by her taking over the tool calibration management and inventory processes. This was an area that had been neglected, in the transition from Intel to the Joint Venture, but Amy quickly restored order, and improved the processes so that they conformed to our Quality Management System, and were straightforward to maintain. When the opportunity arose to transition to design controls lead, a much more demanding and influential position, Amy rose to the challenge gracefully, while also continuing to support the document control team. Amy’s Quality Management System background, combined with her customer-focused approach, made her a critical member of a small but essential part of Care Innovations." and "I highly recommend Amy Pointer as a candidate for employment. Amy and I were employed by Intel – GE Care Innovations focused on product development design controls. Amy eventually reported to me as a design controls mgr, interfacing with multiple project managers, product quality engineers, developers and others. She was essential to the project’s success as she ensured the development of the device was safe and met the customer’s quality expectations. Amy’s successes, however, went far beyond her stated responsibilities. She often stepped in when quality assurance or regulatory affairs expertise was required on-site. Amy received many praises from others at all levels of the organization for her knowledge of quality testing equipment, quality systems, and regulatory affairs. Amy has great communication skills. In addition, she is extremely organized, reliable and detailed oriented. Amy can work independently and is able to follow through to ensure that the job gets done. She is flexible and willing to work on any project that is assigned to her. However, I believe her real talent is her ability to influence project teams and organizational leaders when there is a need for an effective, efficient solution. Amy would be a tremendous asset to any company and has my highest recommendation. If you have any further question with regard to her background or qualifications, please do not hesitate to contact me."
-
Director Of Ra And QaRevmedxPortland, Or, Us -
Director Of Ra/QaRevmedx Aug 2015 - PresentWilsonville, Or -
Director Of Regulatory Affairs & Quality Assurance; Operations ManagerSonivate Medical Dec 2012 - Aug 2015Beaverton, OregonEstablish & Maintain Quality Management System (QMS); Responsible for domestic and foreign regulatory compliance for Class II Devices; Responsible for all Regulatory Submissions and Agency Interactions; Lead efforts for product release in new geographies; Create road maps for Quality, Regulatory and Operations; Responsible for Complaint Handling, CAPAs, Supplier Management and Employee Training systems; Manage Operations, including Supply Chain and Procurement; Oversee contract manufacturers; Guide budgetary requirements related to Quality, Regulatory and Manufacturing; Project Management of Engineering projects and New Product Introduction (NPI) -
Ra/Qa DirectorLab Support (Working For Sonivate Medical) Sep 2012 - Nov 2012Beaverton, OregonPart-time Quality Assurance/Regulatory Affairs Consultant for Sonivate Medical, working toward goal of improving QMS and assist with internal Regulatory processes.
-
Lifecycle Controls (Design Controls) Project ManagerCare Innovations, An Intel Ge Joint Venture Jan 2012 - Aug 2012Develop Design & Development Quality Plans; Ensure adherence to Design Plans and governing QMS processes and procedures; perform internal investigations of processes and procedures, including specific areas such as manufacturing, component qualification; Train new hires on the use of AgileMD & perform back-up Document Control. -
Document Control AnalystCare Innovations, An Intel Ge Joint Venture Jan 2011 - Jan 2012 -
Ra/Qa ManagerQuantrx Biomedical Jun 2007 - Dec 2010Maintenance of Quality Management System; Document Control; Training; Equipment Control; Author documentation (design, manufacturing, SOPs, Work Instructions); Determination of Regulatory Requirements & Classification; Lead/Host regulatory & 3rd party audits; Supplier Controls, qualifications and audits; Internal Audits
-
Manufacturing ManagerOrasure Technologies Sep 1996 - Mar 2004Beaverton, Or
Amy P. Education Details
-
Biology & Psychology
Frequently Asked Questions about Amy P.
What company does Amy P. work for?
Amy P. works for Revmedx
What is Amy P.'s role at the current company?
Amy P.'s current role is Director of RA and QA.
What schools did Amy P. attend?
Amy P. attended Oregon State University, University Of Lancaster.
Who are Amy P.'s colleagues?
Amy P.'s colleagues are John S., Martin Benadik, Rob Lewis, Rob Lewis, Rachel Beeson, Harika Cheemakurthy, Chithra Sen.
Not the Amy P. you were looking for?
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial