Amy P.

Amy P. Email and Phone Number

Director of RA and QA @ RevMedx
Portland, OR, US
Amy P.'s Location
Portland, Oregon Metropolitan Area, United States
About Amy P.

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."

Amy P.'s Current Company Details
RevMedx

Revmedx

View
Director of RA and QA
Portland, OR, US
Website:
revmedx.com
Employees:
9
Amy P. Work Experience Details
  • Revmedx
    Director Of Ra And Qa
    Revmedx
    Portland, Or, Us
  • Revmedx
    Director Of Ra/Qa
    Revmedx Aug 2015 - Present
    Wilsonville, Or
  • Sonivate Medical
    Director Of Regulatory Affairs & Quality Assurance; Operations Manager
    Sonivate Medical Dec 2012 - Aug 2015
    Beaverton, Oregon
    Establish & 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)
  • Lab Support (Working For Sonivate Medical)
    Ra/Qa Director
    Lab Support (Working For Sonivate Medical) Sep 2012 - Nov 2012
    Beaverton, Oregon
    Part-time Quality Assurance/Regulatory Affairs Consultant for Sonivate Medical, working toward goal of improving QMS and assist with internal Regulatory processes.
  • Care Innovations, An Intel Ge Joint Venture
    Lifecycle Controls (Design Controls) Project Manager
    Care Innovations, An Intel Ge Joint Venture Jan 2012 - Aug 2012
    Develop 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.
  • Care Innovations, An Intel Ge Joint Venture
    Document Control Analyst
    Care Innovations, An Intel Ge Joint Venture Jan 2011 - Jan 2012
  • Quantrx Biomedical
    Ra/Qa Manager
    Quantrx Biomedical Jun 2007 - Dec 2010
    Maintenance 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
  • Orasure Technologies
    Manufacturing Manager
    Orasure Technologies Sep 1996 - Mar 2004
    Beaverton, Or

Amy P. Education Details

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?

  • Amy P.

    I/O Psychology, M.A. | Faculty Development Programs
    Detroit Metropolitan Area
  • Amy P

    Vp Operations @ Praxis | Operations Management
    United States
  • Amy Calo

    Talent Acquisition Partner
    Austin, Tx
  • Amy P.

    Senior Recruiter At Energizer Holdings, Inc.
    Greater Milwaukee
  • Amy P

    Actively Looking For Devops/Cloud Engineer Open Positions.
    Charlotte, Nc

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

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.