AbbVie

Assoc Director, Quality

Employer
AbbVie
Location
Pleasanton, CA, United States
Posted
Nov 26, 2020
Ref
205203
Discipline
Quality, Quality Control
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 .

Summary:

Associate Director, Quality is in charge of all aspects of operations quality for the ZELTIQ facilities. Supervise quality personnel in operations quality engineering, supplier quality, production, service and distribution quality, final inspection, and receiving inspection.

Essential Duties and Responsibilities include the following (other duties may be assigned.):

• Oversee and supervise the quality engineering function is the areas of:

o Non-Conforming Material (NCMR) and Material Review Board (MRB) process
o Equipment and Process Validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (OQ)
o Design transfer activities for new product introductions

o Development of Quality Plans and Reports

o Quality Reporting and Trending
• Oversee and supervise Receiving Inspection and Final QC support. Responsibilities include:

o Manage the Receiving Inspection and QC team
o Manage technical support for receiving inspection methodologies, inspection procedures, and sample plans.

• Manage the ZELTIQ Supplier Quality Management program. Responsibilities include:

o Supplier Planning

o Selection of Potential Suppliers

o Supplier Evaluation and Acceptance

o Finalization of Controls

o Delivery, Measurement, and Monitoring

o Feedback and Communication
• Primary Quality Representative for Internal and External Audits for the ZELTIQ operations and service facilities.
• Work cross-functionally with other departments to achieve company and departmental goals.
• Identify and execute on continuous improvement activities including process / product quality improvements.
• Plan and direct activities concerned with development, application, and maintenance of quality standards for processes, materials, and products.
• Compile and write training material and conduct training sessions on quality control activities.
• Plan for resource and capital requirements during the budget cycle and manage the department ' s budget
• Stay up-to-date and follow all procedures related to this job that can affect the quality of products or services provided to our customers.

Qualifications

Qualifications:

• Bachelors degree in biological science or engineering (mechanical, industrial, chemical, electrical) is preferred
• Minimum of 5 years of quality engineering management experience in an FDA-regulated or ISO 13485 manufacturing environment.

• Proficiency with medical device development life cycles and manufacturing processes and technologies.
• Ability to focus on and achieve scheduled milestones, including contingency planning.
• Strong knowledge and understanding of FDA regulations (21CFR 820), ISO13485, and ISO standards related to medical device manufacturing.
• Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
• Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.

Additional Requirements:
• 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.
• Ability to travel up to 25% of the time.

Language and Verbal Skills:
Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
Math Skills:

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Analytical and Reading Skills:
Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
Physical Requirements:
The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; up to 8 hours per day. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.
Work Environment:

Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate.
Safety:
Zeltiq is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

Job Type
Standard

Schedule
Full-time

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.