Company Description

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.

Job Description

Thank you for considering a future opportunity with our company! We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise.

In this talent pipeline requisition, we are not actively recruiting for this position at the moment. However, we are building a network of exceptional individuals who possess the skills and experience required for future openings. By submitting your application to this requisition, you will be added to our talent pipeline and considered for future opportunities.

The Quality Engineer for Combination Products and Devices is primarily 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 include:

• 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.

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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).

Additional Information

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 and long-term incentive programs.

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

Salary: $0 - $0

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.