Sr R&D Quality Assurance Engineer F/M
About the role
Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. 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.
Medical device and combination products quality assurance is essential throughout the Research & Development lifecycle in ensuring patient safety is safeguarded, regulatory compliance, maintaining product quality, and building strong brand reputation.
The R&D Quality Medical Device & Combination Products (MDCP) Senior Engineer will partner with cross-functional team members to ensure medical devices at the Pringy site meet regulatory requirements, quality standards, and customer expectations.
You will act as a true quality partner for R&D teams and support new product development projects and contribute to ensuring that activities comply with internal, regulatory and normative requirements, throughout the product life cycle.
Your main responsibilities are the following :
Support R&D teams in implementing the design control process: you contribute to the preparation, review and approval of product development quality deliverables.
Participate in design reviews, in the analysis of needs and specifications, as well as in the monitoring of design changes after transfer.
Write and approve the 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 the updating of risk analyses in connection with non-compliance processes, changes, design change.
Contribute, with partners, to the establishment of means to guarantee an acceptable level of risk
Coordinate and carry out quality actions relating to the control of R&D clinical product (approval of system documents)
Ensure that the corrective and preventive actions necessary 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 our partners as quality representatives in projects.
Qualifications
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 related field advantageous.
Industry experience in any combination of pharmaceutical, device, combo/device, research development, pharmaceutical manufacturing, quality systems, expertise in aseptic techniques and cleaning, or a combination of those comparable experiences.
Expertise and experience in interpretation and application of quality assurance/controls of regulatory requirements
Skills & Abilities
Communication skills, including superior negotiation and influencing skills. Acute listening skills to gain understanding or to solve a problem and the ability to recognize the difference. Ability to manage difficult conversations and support teams in reaching alignment.
Strong strategic, creative, and big picture thinker. Demonstrated executive presence and ability to anticipate and identify potential issues to address early to mitigate or prevent. Ability to 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 Fillers 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
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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