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 support Medical Device Products.

What You’ll Work On

Internal 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 riskbased 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:

• Medical Device Products

• Medical Device Software

• Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)

• Non Product Software (GxP tools, automated systems)

• Artificial 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 multisite or crossfunctional 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 De Veau 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