Senior Quality Engineer

Company Description
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 – 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
We’re looking for a skilled Senior Quality Engineer to help maintain our commitment to excellence. As a Senior Quality Engineer, you will be responsible for implementing and maintaining the effectiveness of our Quality System, ensuring compliance with company policies and regulations for all of product quality. You will ensure that all quality goals are met and that our practices and procedures comply with company policies.
If you are passionate about driving continuous improvement efforts and have experience in implementing product quality systems, we want to hear from you. As a Senior Quality Engineer, you will have the opportunity to apply your expertise, collaborate with cross-functional teams, and deliver high-quality products.
Join our team of dedicated professionals and take your career to the next level. Apply now to become a part of our organization and help us maintain our commitment to excellence.

Responsibilities:

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Support the 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.
• Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; ensures procedures comply with policy and make sense.
• Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.
• Auditing of commissioning and validation documentation.
• 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.

Significant Work Activities -Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Qualifications

• Bachelor’s degree, preferably in Biology, Chemistry or Engineering
• 6+ years of overall experience in Manufacturing, Quality or Engineering
• Must have Product Quality Experience
• Good verbal and written communication skills.
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting medical device.

Additional Information

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 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

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Support the 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.
• Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; ensures procedures comply with policy and make sense.
• Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.
• Auditing of commissioning and validation documentation.
• 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