Manager, Device Quality Assurance
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 responsibility to represent Operations and QA on cross-functional combination product and medical device development teams to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations and AbbVie’s Quality System requirements. Products transferred to Operations will be of high quality and suppliers will be qualified and meet AbbVie’s high level of quality and compliance expectations.
- Perform Operations 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 the Development Team to ensure design control and risk management documentation are met
- Qualify suppliers per AbbVie’s supplier management procedures and negotiate Quality Agreements
- Support the creation of regulatory submission documentation
- Develop and update key post-market and change control processes to manage products post-launch
- Lead Pre-Market deliverables and associated Design Review
- Identify and anticipate product quality and compliance issues and manage to resolution. gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
- Works independently. Actively leads and participates on development teams. Anticipate/resolve quality issues and take preventative actions. Elevates issues appropriately.
- Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements.
- 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.
- Bachelor’s degree or equivalent is required; preferably in sciences, engineering or other technical/scientific area.
- 7+ years of total combined experience. At least 5 years in Quality Assurance; 3 years in Operations, Research and Development or Consulting. Less experience considered with advanced degree. Medical device experience required. Combination Product and supplier management experience desired.
- Strong understanding of regulations and standards affecting combination products and medical devices.
- Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.
- 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 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
Yes, 10 % of the Time
Job Level Code
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.