Sr R&D Quality Assurance Engineer

Sr R&D Quality Assurance Engineer

AbbVie

Annecy, France

Job Description

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.