Sr. Manager, Quality Engineering
Posted on: May 20, 2023
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.Sr. Manager, Quality
Engineering Primary Pleasanton, California Req ID R00079731
Category Quality Assurance Division AbbVie Overview
The Senior Manager, Quality Engineering provides leadershipand
direction to the quality function they are responsible for within
Operations. This Sr. Manager role will collaborate to drive
validation of product and processes, quality engineering,
regulatory compliance, quality planning, process compliance,
improvements, and risk mitigation. This role will also oversee
direct reports supporting AbbVie quality systems and quality
oversight for the plant and strategic initiatives. This great
opportunity will afford the selected candidate the ability to have
exposure to and exert influence on diverse teams of people in a
target rich environment.Responsibilities
- Participate in design reviews, Risk Management, Validation,&
Verification plans and reports during Product Development as
- Responsible for Design Transfer activities for new product
introductions internally or externally, ensuring quality and
manufacturing process readiness.
- Support and/or drive Equipment and Process Validation,
including Installation Qualification (IQ), Operational
Qualification (OQ), and Performance Qualification (OQ), internally
- Provide quality inputs and/or requirements as applicable.
- Manage and support other quality tasks as required.
- Recognize/anticipate barriers to completing assigned
- Focuses and determines proper engineering principles on
- Drive and own quality assurance and requirements during
development phases and post-market release.
- Implement lessons learned in other/new products, respectively
new or running projects.
- Identify and manage Critical to Quality (CTQ's)
- Adhere to defined and communicated corporate quality
requirements, applicable regulatory affairs and standards, methods,
and procedures, with aptitude for identifying improvements.
- Focus on streamlining activities for increased
- Development of Quality Plans and Reports.
- Builds positive culture and develops team members while
overseeing the department. Monitors team workload, guides team
through complex work issues, and answers questions. Interviews,
hires, and recommends salary adjustments for team members as
- Collaborates with team members to establish performance goals,
conducts performance reviews, and assists with succession
- Bachelor's degree in biologicalscience or engineering
(mechanical, industrial, chemical, electrical), or closely related
discipline is required, or equivalent technical experience. A
post-graduate education/degree is desired and may contribute
towards the desired years of experience.
- Demonstrated competency with desired 8+ years of significant
quality engineering and/or operations experience including a
minimum 5 years' experience in an electro-mechanical, assembly and
test manufacturing environment. Must have demonstrated people
leadership experience/leading successful team(s).
- Proficiency with medical device development life cycles and
manufacturing processes and technologies.
- Ability to focus on and achieve scheduled milestones, including
- Advanced knowledge of Design Control and Design Transfer.
- Responsible for performing all duties in compliance with FDA's
Quality System Regulation (QSR), ISO 13485, ISO 14971, and all
other international regulatory requirements with which
- Excellent analytical skills.
- Certified Six Sigma Black Belt, Green Belt or Lean Master
preferred, with proven completion of projects in which solutions
were sought at the root level of the problem.
- Experience working in cross-functional, cross-business and
- Proven Leadership and Change Management experience driving
process improvement projects.
- Hands-on and possesses a strong sense of teamwork.
- Supplier Development and Management experiences.
- Ability to travel up to 10% of the time.
- Demonstrated written and verbal communication skills.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 ingood faith it will pay for
this role at the time of this posting based on the job grade for
this position. Individualcompensation paid within this range will
depend on many factors including geographic location, and we may
ultimatelypay more or less than the posted range. This range may be
modified in thefuture.We offer a comprehensive package of benefits
including paid time off. (vacation, holidays, sick),
medical/dental/visioninsurance and 401(k) to eligibleemployeesThis
job is eligible to participate in our short-term incentive
programs.This job is eligible to participate in our long-term
incentive programs.Note: No amount of payis considered to bewages
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
benefitsthat are allocable to a particular employee remains in the
Company's sole and absolute discretion unless and until paid andmay
be modified at the Company's sole and absolute discretion,
consistent with applicable law.AbbVie is an equal opportunity
employer including disability/vets. 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 disabled veteran, recently separated
veteran, Armed Forces service medal veteran or active duty wartime
or campaign badge veteran or a person's relationship or association
with a protected veteran, including spouses and other family
members, or any other protected group status. We will take
affirmative action to employ and advance in employment qualified
minorities, women, individuals with a disability, disabled
veterans, recently separated veterans, Armed Forces service medal
veterans or active-duty wartime or campaign badge veterans. The
Affirmative Action Plan is available for viewing in the Human
Resources office during regular business hours.Join our talent
network and receive AbbVie news and job alerts to your inbox. First
name Last name Email address Phone number Interested In Please
select a category or location option. Click "Add" to create your
job alert. Category Location
- Quality Assurance, Pleasanton, California, United States Remove
Confirm Email Phishing scam alertAs an online job seeker, you could
be a target of cyber (online) thieves seeking to secure personal
information from you by sending you "phishing" messages. Please be
alert to and protect yourself from phishing scams. Find out how you
can avoid being a victim of job phishing scams.
Keywords: Allergan, Pleasanton , Sr. Manager, Quality Engineering, Executive , Pleasanton, California
Didn't find what you're looking for? Search again!
Loading more jobs...