Senior Quality Engineer

Company Description

AbbVies 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 peoples lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Purpose Statement (2-3 Sentences):

The Senior Quality Engineer is responsible for carrying out the Quality Assurance functions within the Global team including management of change plans (internal and supplier initiated), performance of change/product impact analysis, complaint analysis, resolution of internal & supplier NCRs, Deviations, corrective and preventive action for events, leading and participating in investigations, review and approval of test methods and product specifications, support quality plans, and assurance of cGMP and AbbVie policy compliance for the area of responsibilities. Supports the team by reviewing and approving validation protocols and reports. Other quality assurance tasks assigned by the functional leadership.

Major Responsibilities:

Responsible for implementing and maintaining the effectiveness of the Quality System.

Support and ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.

Ensure investigations of the Exception Reports (ERs)/Supplier Events are completed thoroughly and documented accurately and are included in the CAPA system. Performs product impact analyses for the ERs.

Maintains an effective and cooperative relationship with other Quality areas, and cross functional teams (internal and external).

Owns and manages the Change Plan (CP) process and execution for the function. Ensure timely completion of the CP tasks. Co-ordinate and present in the Cross Functional Team (CFT) and Change Review Board (CRB) meetings.

Review/approve standard operating procedures; ensures procedures comply with policy and make sense.

Manage the Pre and Post Market Reviews for the products within the functional area responsibilities. Support Design Transfer Reviews.

Support and oversee field complaints and data analysis for the complaints. Share updates and present information to various leadership forums.

Develops product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEA’s. Develops and implements statistical quality programs and process monitoring systems.

Support supplier batch review and release process.

Qualifications

Qualifications:

Bachelors degree, preferably in Biology, Chemistry or Engineering.

Master’s degree preferred.

6 years of overall experience in Medical Device Manufacturing, Quality or Engineering.

Strong verbal and written communication skills.

Good problem solving and analytical skills

Good interpersonal relations / communications skills

Good negotiation skills

Working knowledge of quality / compliance management as well as regulations and standards affecting Medical Devices and Combination products.

Additional Information

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

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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. ​

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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 Companys sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Salary: $80,500 – $153,000