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Senior Quality Engineer, Medical Device & Combination Product Quality Systems at Abbvie
AbbvieNorth Chicago, IL, us·2h ago
Entry LevelFull-time
Salary Range
$51,000 - $69,000 /year
This salary is estimated based on similar roles. The actual salary may vary.
• Supports External Audits in Front Room or Back Room lead capacities, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits under MDSAP.
• Conduct Internal Audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
• Subject Matter Expert in both current and emerging regulations and standards impacting AbbVie medical device and combination products, performing regulatory compliance assessments to support business decision-making.
• Serves as Process Owner of QMS process of moderate complexity, advancing process sustainment & improvement independently through effective project management.
• Performs root cause investigation and corrective action planning in response to external and internal audit observations of moderate risk, in collaboration with departmental process owners and subject matter experts.
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About Abbvie
Abbvie is a global biopharmaceutical company specializing in the research, development, and commercialization of innovative therapies. Headquartered in North Chicago, Illinois, the company was founded in 2013 following the spin-off of Abbott Laboratories' pharmaceutical division. Abbvie operates at the forefront of the biotechnology and pharmaceutical industries, focusing on addressing complex diseases and improving patient outcomes through scientific advancement. The company's primary products include treatments for immunology, oncology, and neurology, with its flagship drug, Humira, being one of the best-selling medications globally. Abbvie is known for its robust pipeline of investigational therapies, leveraging cutting-edge research and clinical trials to bring novel treatments to market. Its target audience includes patients, healthcare providers, and payers, with a particular emphasis on those suffering from chronic and life-threatening conditions. Key features of Abbvie's offerings include targeted therapies, personalized medicine approaches, and a commitment to regulatory compliance and safety. Abbvie has achieved significant milestones, including maintaining a leading position in the global pharmaceutical market and generating substantial revenue through its innovative portfolio. The company's unique value proposition lies in its dedication to scientific excellence and patient-centric care, supported by a strong pipeline and strategic investments in research and development. Abbvie's market position is further strengthened by its global reach, collaborative partnerships, and a reputation for delivering transformative therapies.
