Sr. Manager, Quality Engineering

Company: Allergan
Location: Pleasanton
Posted on: May 20, 2023

Job Description:

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 required.
• 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 or externally
• Provide quality inputs and/or requirements as applicable.
• Manage and support other quality tasks as required.
• Recognize/anticipate barriers to completing assigned work/projects.
• Focuses and determines proper engineering principles on reliability issues.
• 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 efficiencies.
• 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 needed.
• Collaborates with team members to establish performance goals, conducts performance reviews, and assists with succession planning.Qualifications
  • 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 contingency planning.
  • 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 ABBVIE/ZELTIQ complies.
  • 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 cross-cultural projects.
  • 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