AbbVie

Sr Supplier Quality Engineer

Employer
AbbVie
Location
Branchburg, NJ, United States
Posted
Sep 29, 2020
Ref
203657
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its 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

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

Sr. Supplier Quality Engineer

What Your New Manager Wants You To Know

Under the supervision of supplier quality management, the Supplier Quality Engineer/Analyst III (Sr. Supplier Quality Engineer/Analyst) will support all aspects of the Supplier Quality processes which include but not limited to the activities listed below. Complies with FDA, ISO, AATB, and all other applicable international and state regulatory requirements, best industry practices and internal processes. Identify and bring issues to management when a compliance gap or quality issue is identified.

YOU ARE more than just a title, YOU ARE...

A strategic thinker : Align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.

First class team player : Collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will

  • Monitor the performance of suppliers on a continuous basis and escalates any potential issues to supplier quality management.
  • Supports the completion of supplier risk assessments and updates supplier quality database accordingly.
  • Ensures supplier quality database is updated timely with any new information/addition, and ensures its accuracy, i.e., supplier evaluation criteria are maintained, and supplier files are current.
  • Compiles metrics for Supplier Quality Systems for internal stakeholders, tier boards and Quality System Management Review, as needed.
  • Communicates supplier quality related risks to LifeCell's business to management.
  • Supports internal/regulatory audits on supplier quality related requests.
  • Ensures all supplier related NCRs are processed/closed timely.
  • Communicates supplier NCRs/SCARs to Suppliers and necessary follow-up actions are performed and documented timely per procedure requirements.
  • Obtains necessary documentation required from suppliers to support material release at LifeCell.
  • Reviews/approves GTW supplier NCRs/SCARs records, ensures supplier root cause investigations, CAPA actions and ECs are appropriate in preventing recurrence.
  • Works with suppliers to ensure supplier investigations and CAPAs are robust and will drive to resolve root cause.
  • Ensures all supplier change notification records are created timely in GTW, and notifications for shared suppliers are communicated to Corporate Supplier management group timely.
  • Assigns assessment actions to SMEs and works with cross functional SMES and suppliers to complete the assessments timely.
  • Provides feedback to suppliers related to change notifications and ensures necessary follow-up actions are completed as required.
  • Follows up to ensure required internal changes resulted from supplier change notifications are implemented timely
  • Reviews/approves Global TrackWise supplier change notification records.
  • Processes/coordinates LifeCell requested changes with suppliers as needed and ensures their timely completion.
  • Leads/participates assigned supplier quality audits per schedule.
  • Ensures GTW audit records of assigned audits are created and completed timely as required.
  • Completes and submits audit observations memos and audit reports timely.
  • Reviews/approves supplier audit reports and Global TrackWise audit records.
  • Follows up with suppliers and ensures audit observations are resolved properly and closed timely, and GTW audit records are closed timely and properly.
  • Follows up with suppliers on pending surveys. Reviews/approves assigned supplier surveys.


Qualifications

You Bring

• BA/BS in Technical Field is required.

• Have a minimum of 5 years of experience working in Quality/compliance role.

• Must have experience in leading Supplier Quality audit for a minimum of two years.

• Excellent technical writing and verbal communication skills.

• Able to travel up to 50%.

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

• Professional auditing certification by ISO, ASQ, or similar body (preferred)

• Experience in TrackWise system

• Direct experience in leading supplier quality investigations and CAPA activities.

  • I n-depth Knowledge of relevant regulations/standards, i.e., ISO13485, FDA 21CFR820, FDA 21CFR1271, AATB, etc.
  • Ability to train others.
  • Experience in identifying/initiating quality system/process improvement.
  • Ability to work varied schedule with some potential weekend and evening hours when needed.


At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.

Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.