Manager, R&D Quality
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.
Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.
What Your New Manager Wants You To Know
The primary responsibility of the Manager, R&D Quality position is to assume a lead role in providing Design Quality support for existing products on the market and new product development projects. This position will interface with Leaders in Development, Sustaining Engineering, Regulatory, Quality Management and Post Market Surveillance to ensure new products under development and existing products on the market comply with applicable internal and external requirements.
YOU ARE more than just a title, YOU ARE…
First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.
Design Control Activities:
- Collaborate with Design teams, provide technical support, and facilitate the successful execution of the Design Control Process.
- Responsible for Quality Engineering deliverables required within the product development process.
- Support Design Verification and Validation activities, including review of verification & validation protocols and reports
- Assist in the analysis of product requirements and specifications. Participate in product design reviews and team meetings.
- Provide subject expertise and input in the following areas: Biocompatibility strategy, including requirements, protocol, and report; Shelf-Life Studies strategy, including accelerated and real-time; Cleaning Validation.
- Interface with all departments to provide leadership on the use of Quality Engineering methodologies, tools, regulatory compliance requirements.
- Lead/coach/guide Engineers to facilitate compliance and to support process improvements.
- Ensure that technical information is accurate and in compliance with quality and regulatory requirements.
- Implement Design Control process improvements to ensure a more effective, efficient, and compliant design control process.
- Perform DHF Audits throughout the development process
Risk Management Activities:
- Maintain and manage the overall ZELTIQ Risk Management process in accordance with ISO 14791 and other applicable standards. Work cross-functionally with the Subject Matter Experts from R&D, Clinical, and Operations to ensure a comprehensive risk management process.
- Implement New Risk Management Process, Procedures, and Templates and help migrate and update current risk management documents to new process.
- Manage Post-Market Surveillance and Feedback into the Risk Management File.
- Manage Production Data into the Risk Management File.
- Perform Risk Reviews for all Risk Management Files as required.
Usability Engineering Activities:
- Implement new Usability Process, Procedure and Templates and provide support to the transition to new Usability processes.
- Provide quality support for the Usability plan, report, and file.
General Quality Activities:
- Develop of Quality Plans, as required
- Maintain and Manage the DHF after product commercial release including reviewing and verifying design changes, line extensions, new indications, etc.
- Ensure that technical information is accurate and in compliance with international regulatory requirements.
- Represent RDQA during internal or external audits as required.
- Generate and revise relevant procedures
- Prepare and analyze quality trend data
- Support the resolution of CAPAs to closure and verification of effectiveness
- Perform all duties with minimal oversight required from direct manager
- Bachelor’s degree in Engineering or Science.
- Minimum of 7 years of quality engineering experience in an FDA regulated medical device manufacturing environment.
- Advanced knowledge of, and proficiency with medical device development life cycles and Design Control processes.
- The ability to handle complex issues and exercise judgement, based on experience, with minimal oversight from manager.
- Knowledge of QSR, ISO 13485, and ISO 14971
- Knowledge of IEC 62366, IEC 60601, Biocompatibility, and Aging Studies preferred
- The ability to write Verification / Validation protocols and reports.
- Six sigma green belt preferred.
- Competent using office software including MS Word, Excel, PowerPoint, and Outlook.
In this role, we’re looking for a leader who will:
- Act as an Owner
- Be Excellence Focused
- Act as an Influencer
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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.