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Quality Engineer IV

AbbVie

This is a Contract position in Lexington, KY posted January 1, 2022.

About AbbVieAbbVie’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.Summary: This role is responsible for quality support for New Product Introduction (NPI) and Supplier Process Validations of Zeltiq manufactured products.

Essential duties and responsibilities include the following (other duties may be assigned): Responsible for driving continual process improvements in responsible areas of the business.

Drive quality and manufacturing improvements to assure that processes are in a state of control.

Develop and maintains effective relationships and integrate activities with other departments and suppliers.

Review and approve changes made to product and processes and validation/qualification protocols and reports.

Review specifications and design documents for manufacturing software tools and provide feedback.

Provide guidance on Manufacturing Test Software and Equipment Validation Strategies Involved in Supplier Processes, (e.g.

but not limited to) Review Supplier Validation Protocols and Reports Draft/Provide Supplier Validation Protocols & Reports where required Review Supplier pFMEAs and Master Validation Plans where required Review Supplier Tooling requirements where required Work in conjunction with Supplier Quality Group to coordinate any Supplier Validation activities Set up QA best practices to ensure that manufacturing software is developed and implemented with high quality.

Work with internal customers and suppliers to ensure that process validation related non-conformances, failure analysis reports and deviations are appropriately investigated, documented, reviewed and approved.

Responsible for drafting and/or updating Quality Procedures for Quality Operations functions.

Initiate and develop standards and methods for inspection, testing, and evaluation as necessary.

Assure product compliance to specifications through implementation of inspection criteria, procedures and training.

Establish and maintain quality metrics.

Provide guidance (& sign off where necessary) to Manufacturing Change Requests requiring validation.

Provide guidance (& direct input where necessary) to Manufacturing Customer Focus Teams on process validation related activities.

Identify and lead projects and initiatives to improve the quality system.

Any other responsibilities assigned by manager.

Ability to travel 15% of the time.

Qualifications Bachelor’s degree in engineering or other technical discipline, or advanced degree in other disciplines, or equivalent experience.

Minimum of 2 years of quality engineering or equivalent experience in FDA regulated medical device manufacturing environment(s).

Experience working with medical devices with significant software controls and good understanding of software development life cycle desired.

Experience with software development on Windows OS is Proficiency in reading and interpreting mechanical drawings and GD Knowledge of QSR and ISO 13485.

Medical Device Auditor certification preferred.

Problem solver.

Self-directed.

Additional Requirements:
• Knowledge of quality/continuous improvement tools (SPC, Statistics, DOE, Six Sigma) preferred
• Good oral and written communication skills.

• Ability to write reports, data analysis, and business correspondence.

• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

• Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members.

• Ability to work with mathematical concepts such as probability and statistical inference.

• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

• Ability to use MS Excel to perform calculations and interpret results/data.

• Ability to define problems, collect data, establish facts, and draw valid conclusions.

• Ability to read technical literature and documents and extract important concepts.

• Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.

Significant Work ActivitiesContinuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)TravelNoJob TypeExperiencedScheduleFull-timeJob Level CodeICEqual Employment OpportunityAt 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.