Digital Health Quality Specialist - AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Come to work each day with an inclusive and collaborative Business technology team! As an Digital Health Quality Specialist in AbbVie Business Technology Solutions (BTS), you’ll have opportunities to contribute to the digital transformation of a leading biopharma company, helping to create solutions that impact patients and their communities for the better.

***This is a hybrid role based in Lake County, IL***

Primarily responsible for representing QA on cross-functional Software as a medical device (SaMD) and Digital Health Software product development teams and executing Quality System requirements to ensure products are developed, tested, and released in compliance with worldwide Medical Device Regulations. Responsible for authoring, reviewing, and approving project documentation associated with the SDLC and design control requirements to support Corporate, Division, FDA, and other regulatory requirements. In addition to these primary areas of focus, quality assurance will also be responsible for creating and maintaining QMS documents for the development of SaMD’s and Digital Health Software Products in compliance with global regulations.

Responsibilities

• Perform QA activities related to Software as a Medical Device (SaMD) and Digital Health Software Product Development
• Ensure compliance with AbbVie’s software lifecycle policies and procedures.
• Perform design control and risk management activities (including cybersecurity risk management) according to AbbVie's Quality System
• Partner with technical teams to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met.
• Support the creation of regulatory submission documentation.
• Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
• Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
• Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements.
• Write/review policies/processes/procedures and related documents for the development of SaMD’s and Digital Health products in compliance with global regulations.
• Apply knowledge of global regulations, guidance's, and Corporate and Function standards.
• Assist in the preparation of and support regulatory agency and internal audits.

Required:

• Bachelor’s degree or equivalent is required; preferably in sciences, engineering or other technical/scientific area with 4+ years of industry experience in Quality Assurance, Development or healthcare related field. Master’s Degree with 2+ years of experience. 
• • Strong understanding of regulations and standards affecting software medical devices such as IEC 62304, ISO 14971, 21 CFR 820.30 and EU MDR.
  • Experience with creation and maintenance of QMS documents for development of medical devices.
  • Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills.
  • Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management.
  • Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues.
  • Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities.
  • Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required.
  • Capable of clearly presenting and justifying quality requirements to management.

Beneficial:

• Experience in Medical devices, specifically development of Software Medical Devices..

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html