AbbVie

Quality Engineer, Combination Products & Medical Devices

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Feb 12, 2021
Ref
2102396
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Primary responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations.

Responsibilities:
  • Perform QA activities related to Combination Product and Medical Device Development:
    • Ensure compliance with company policies and procedures.
    • Perform design control and risk management activities according to AbbVie's Quality System
    • Partner within Quality and R&D to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met
    • Perform 3rd party supplier management activities such as review 3rd party design control activities
    • 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
  • Apply knowledge of global regulations, guidance's, and Corporate and Function standards.
  • Lead/assist in the preparation of and support regulatory agency and internal audits.

Qualifications

Qualifications:
  • Bachelor's degree or equivalent is required; preferably in sciences, engineering or other technical/scientific area.
  • 4+ years of industry experience in Quality Assurance, Development or healthcare related field. Less experience considered with advanced degree. Medical device experience required. Combination Product and 3rd party supplier management experience desired.
  • Strong understanding of regulations and standards affecting combination products and 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
  • Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).

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)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.