Staff Auditor, Quality Systems- Medical Devices job opportunity at Abbott.

Home Jobs In United States Of America Tag: Quality Systems- Medical Devices Staff Auditor, Quality Systems- Medical Devices position at Abbott


DatePosted 5 Days Ago bot
Abbott Staff Auditor, Quality Systems- Medical Devices
Experience: 16-years
Pattern: full-time
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Quality Systems- Medical Devices

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loacation United States - Minnesota - Minnetonka, United States Of America
loacation United States ..........United States Of America

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.       JOB DESCRIPTION: The Opportunity   We are seeking an experienced Quality Systems   Auditor   with expertise in medical device   and   software auditing to support internal audit program   required for compliance with global regulatory standards and collaborating with Abbott Medical Device Business   Units for external inspection preparation and support.    This role   will s upport   M edical   D evice   Products .     What You’ll Work On   I nternal audit planning, developing audit schedules and plans, performing and documenting audits and managing related following up activities including related KPI and metrics reporting.     Support the development, training, and supervision of auditors to improve their ability to provide inspection readiness support.     Lead and mentor staff, influence colleagues and peers, and continually strive to improve the audit and inspection readiness programs.    Provide leadership, oversight, and project management covering external inspections as related to Abbott's Quality System. This includes division / business support, quality/regulation expertise and consulting activities.    Lead the planning, development, and implementation of internal audit schedules and risk based audit plans, specifically incorporating software lifecycle and validation requirements.   Conduct in-depth Quality System audits across Abbott manufacturing sites .   Perform detailed assessments of software development and validation practices, cybersecurity controls, risk management (ISO 14971), and documentation for technical completeness and compliance.   Evaluate adherence to global regulations and standards including:    FDA 21 CFR Parts 11 & 820   ISO 13485     Required Qualifications   Bachelors Degree (± 16 years), Related field OR an equivalent combination of education and work experience,     Masters Degree (± 18 years) Preferred      Minimum 6 years, Related work experience with a strong understanding of specified functional area.    Solid understanding and application of business concepts, procedures and practices.    Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.    Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.    Has a sound knowledge of a variety of alternatives and their impact on their business unit.      Preferred Qualifications   Prior experience performing or leading audits focused on:    M edical   D evice   Products   Medical Device Software   Software as a Medical Device (SaMD)   and   S oftware in a Medical Device (SiMD)   Non Product Software (GxP tools, automated systems)   A rtificial Intelligence     Strong working knowledge of software and device regulations and standards:    IEC 62304, ISO 13485, ISO 14971   FDA 21 CFR Parts 11 & 820   EUMDR   GAMP 5 CSV principles     Experience preparing for and supporting FDA or global regulatory inspections.   Experience   managing multi site or cross functional projects to completion.   Excellent technical writing and communication skills, including executive-level reporting.   Lead Auditor certification (e.g., ISO 13485 Lead Auditor) desirable.   Ability to travel   25–50% , sometimes with short notice.         The base pay for this position is $78,000.00 – $156,000.00 In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Operations Quality       DIVISION: MD Medical Devices          LOCATION: United States > Minnesota > Minnetonka : 14901 DeVeau Place       ADDITIONAL LOCATIONS: United States > Maple Grove : 6820 Wedgwood Road N., United States > Massachusetts > Burlington : 168 Middlesex Turnpike, United States > Minnesota > Plymouth : 5050 Nathan Lane N, United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza, United States > Minnesota > St. Paul > Tech Center : One St Jude Medical Drive, United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B, United States > Santa Clara : Building B - SC, United States > Sylmar : 15900 Valley View Court, United States > Temecula : 41093 County Center Drive, United States > Texas > Plano : 6600 Pinecrest       WORK SHIFT: Standard       TRAVEL: Yes, 50 % of the Time       MEDICAL SURVEILLANCE: No       SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)       Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.       EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf       EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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