Senior Quality Engineer, Medical Device External Quality

The Senior Quality Engineer, Medical Device External Quality is part of AbbVie’s External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality.  The role will be based out of Lake County, IL site or Pleasanton, CA. This role primarily oversees external product quality assurance (EPQA) for commercial medical devices which are manufactured by third parties (TPM).  In this capacity, the Manager, Medical Device External Quality, champions best practices related to sustaining supplier qualifications, product quality, equipment qualification, and manufacturing process validations.  As such, the Manager, Medical Device External Quality works closely with AbbVie’s Contract Manufacturing Organizations (CMOs), relevant third-party suppliers (e.g., custom components and finished devices), and internal stakeholders to ensure compliance with defined specifications and regulatory requirements.

Responsibilities

• Manages CMOs and/or third-party suppliers to assure timely and compliant release of commercial products and/or components in accordance with defined specifications and processes.
• Oversee CMOs and/or third-party suppliers to ensure that non-conformances, CAPAs, Reworks, and deviations are accurately documented, reviewed, and approved as well as resolving compliance issues related to commercial product and/or custom components
• Supports Late-Stage Development and/or New Product Introduction (NPI) activities
• Develops and maintains supplier Quality Technical Agreement. Review and approve changes to supplier processes which impact device and/or component manufacture.
• Review and approve technical protocols, reports, and specifications, as appropriate.
• Participates in the development of global Product Quality Assurance strategy to support medical devices and/or combination products produced at third party manufacturing (TPM) facilities.
• Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers if required.
• Interfaces with Global Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Support Supplier Audit function during CMO site audits.
• Leads quality reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues.  Champions development and maintenance of KPIs and trend analysis at supplier site, as applicable
• Bachelor’s degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred with at least 7 years in a regulated medical device industry.
• Minimum of 6 years of quality engineering experience in FDA regulated medical device manufacturing environment(s).
• Proficiency in reading and interpreting mechanical drawings and GD&T.
• Knowledge of QSR and ISO 13485.
• Medical Device Auditor certification preferred.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at  the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors  including  geographic location, and we may ultimately  pay more or less than the posted range. This range may be  modified in the future. ​
• 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 incentive programs.  Note: No amount of pay is  considered to be wages or compensation until such amount is earned,  vested,  and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a   particular employee  remains in the Company's sole and absolute discretion unless and until paid and may be  modified at the Company’s sole and absolute discretion,  consistent with applicable law.

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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