Future Opportunities - Join Our Talent Pipeline for Quality Engineer, Combination Products and Devices

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.

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. 

Join our dynamic and forward-thinking R&D Quality Engineering team at AbbVie, where innovation is at the heart of everything we do. As a leader in this team, you will play a crucial role in driving excellence and ensuring compliance in our cutting-edge New Product Development projects. With a specific focus on complex electromechanical medical devices, you will be responsible for managing risk assessments, overseeing design changes, and maintaining essential documentation. Your problem-solving skills and expertise in biocompatibility, design control, and risk management will be highly valued in this fast-paced environment.

At AbbVie, we are passionate about improving patient outcomes, and we believe that collaboration is key to achieving success. By joining our team, you will have the opportunity to make a significant impact and be a key player in our ongoing success story. If you are ready to contribute to our mission and thrive in a collaborative setting, we invite you to apply now and be a part of our AbbVie family.

The primary responsibility of these positions is to lead and facilitate Quality Engineering support for New Product Development projects. This includes ensuring compliance to applicable internal and external requirements during the product development cycle and the commercialization of new products, assisting in risk assessments, dealing with design changes, maintaining Design History Files, and managing local Quality System processes for Design Control. This department requires individuals capable of solving complex problems, exercising judgment based on experience, applying statistical methods for data analysis and complying with procedures.

Responsibilities:

• Lead Design Control activities and provide Quality Engineering support for design projects involving complex electromechanical medical devices.
• Analyze product requirements and specifications, participate in product design reviews and team meetings.
• Provide subject expertise in areas like Biocompatibility strategy, Shelf-Life Studies strategy and Cleaning Validation.
• Main responsibility for Quality Engineering deliverables within the product development process.
• Review Design Changes after design transfer.
• Support Design Verification and Validation activities.
• Manage and maintain the site Risk Management process in accordance with ISO 14791 and other applicable standards.
• Facilitate the development of User Needs, Usability plans, reports, and files in Usability activities
• Implement Design Control/Risk Management process improvements.
• Develop Quality Plans, conduct DHF Audits throughout the development process, and maintain and manage the DHF after product commercialization.
• Generate and revise relevant procedures, prepare and analyze quality trend data, support CAPA resolution and verification of effectiveness.

• Minimum bachelor's degree in science or engineering.
• 5 to 10+ years of quality engineering or related experience in an FDA regulated medical device environment.
• Proficiency with medical device development life cycles and Design Control processes.
• Knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62366, IEC 60601 with emphasis on Biocompatibility and Aging Studies.
• Ability to write Verification / Validation protocols and reports.
• Strong communication skills to effectively interact with internal and external partners and regulatory bodies.

Preferred Skills:

• Understanding of Medical Device software requirements.
• Six sigma green belt and/or ASQ CQE certifications.
• Competency in office software tools like MS Word, Excel, PowerPoint, and Outlook.

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 

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