Sr. Manager, Quality Engineering

Overview
The Senior Manager, Quality Engineering provides leadership and 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

• Manage and support other quality tasks as required.
• Recognize/anticipate barriers to completing assigned work/projects.
• Provide quality inputs and/or requirements as applicable.
• Support and/or drive Equipment and Process Validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (OQ), internally or externally
• Identify and manage Critical to Quality (CTQ’s)
• Implement lessons learned in other/new products, respectively new or running projects.
• Adhere to defined and communicated corporate quality requirements, applicable regulatory affairs and standards, methods, and procedures, with aptitude for identifying improvements.
• Responsible for Design Transfer activities for new product introductions internally or externally, ensuring quality and manufacturing process readiness.
• 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.
• Focuses and determines proper engineering principles on reliability issues.
• Focus on streamlining activities for increased efficiencies.
• Collaborates with team members to establish performance goals, conducts performance reviews, and assists with succession planning.
• Drive and own quality assurance and requirements during development phases and post-market release.
• Participate in design reviews, Risk Management, Validation, & Verification plans and reports during Product Development as required.

Qualifications

• Ability to focus on and achieve scheduled milestones, including contingency planning.
• Excellent analytical skills.
• Supplier Development and Management experiences.
• Bachelor's degree in biological science 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.
• 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.
• 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.
• Proven Leadership and Change Management experience driving process improvement projects.
• 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).
• Hands-on and possesses a strong sense of teamwork.
• Ability to travel up to 10% of the time.
• Demonstrated written and verbal communication skills.
• Experience working in cross-functional, cross-business and cross-cultural projects.
• Proficiency with medical device development life cycles and manufacturing processes and technologies.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• We offer a comprehensive package of benefits including paid time off. (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• This 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 pay is considered to be wages 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 benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may 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.