Sr R&D Quality Assurance Engineer F/M

Job Overview

AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues. As a quality organization in research & development, R&D Quality Assurance is committed to driving quality excellence across all stages of discovery and development for the product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients.

Responsibilities

• Support R&D teams in implementing the design control process: prepare, review, and approve product development quality deliverables.
• Participate in design reviews, analyze needs and specifications, and monitor design changes after transfer.
• Write and approve deliverables of the design files as well as the resulting quality documents (e.g., specifications, protocol, and R&D stability reports).
• Ensure product compliance through the risk management process throughout the product life cycle.
• Ensure updating of risk analyses in connection with non‑compliance processes, changes, design changes.
• Contribute with partners to establish means to guarantee an acceptable level of risk.
• Coordinate and carry out quality actions related to the control of R&D clinical product (approval of system documents).
• Ensure that corrective and preventive actions following a non‑compliance are implemented, monitored, and their effectiveness verified.
• Support investigations when there is a problem to be solved.
• Deploy the quality culture with partners as quality representatives in projects.

Education & Experience

• Bachelor’s degree required, preferably in biomedical engineering, mechanical engineering, chemical engineering, pharmaceutical sciences, or related discipline. Master’s or Ph.D. in a related field advantageous.
• Industry experience in pharmaceutical, device, combo/device, research development, manufacturing, quality systems, expertise in aseptic techniques and cleaning, or comparable experiences.
• Expertise and experience in interpretation and application of quality assurance/control regulatory requirements.

Skills & Abilities

• Communication skills, including superior negotiation and influencing skills, acute listening, ability to manage difficult conversations and support teams in reaching alignment.
• Strong strategic, creative, big picture thinking, demonstrated executive presence, ability to anticipate and identify potential issues early to mitigate or prevent, consult on difficult decisions under pressure.
• Ability to facilitate instructor‑led training programs on complex quality assurance/control topics (e.g., ISO13485, FDA regulations, 21 CFR Part 820, and other applicable worldwide and regional regulations).
• Ability to partner with cross‑functional teams at the site and globally to support new product development initiatives and drive the quality culture at the site.
• Ability to prioritize and balance multiple tasks simultaneously and satisfy stakeholders.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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