Abbott

Quality Assurance Manager

Abbott • $99K — $198K *
Westfield, IN 46074In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • B.S. in Engineering or related field; or equivalent combination of education and work experience.
  • 8-10 years in roles of increasing responsibility within a manufacturing support environment in quality.
  • 3-5 years in a supervisory/leadership role.
  • Proven track record in nonconformance management and cost containment.
  • Strong project management skills and ability to work in a matrixed business environment.

Responsibilities

  • Implement staffing plans and coordinate the selection process with HR.
  • Develop direct reports through training and formal reviews.
  • Monitor daily operations and provide guidance to staff to achieve goals.
  • Interact with stakeholders and explain procedures as necessary.
  • Contribute to policy development that affects work processes and personnel.
  • Monitor compliance with company policies and regulatory requirements.
  • Identify and implement processes for department performance improvement.

Benefits

  • Comprehensive health and wellness benefits for employees and their families.
  • A supportive work environment that promotes career advancement.
  • Diverse opportunities within the organization to build your future.
  • Opportunities for professional development and training programs.
Full Job Description
JOB DESCRIPTION:

Quality Assurance Manager

The Opportunity

This position works out of our Westfield, IN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

The Quality Assurance Manager is accountable for the Quality Operations Organization and leads a team of Quality supervisors/technicians/inspectors/specialists to support Manufacturing, Supplier Development, New Product Development, Distribution/Warehouse Value Added Services, and Quality Systems. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements.

What You'll Work On
  • Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
  • Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
  • Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
  • Interacts with internal and external stakeholders, by meeting regularly, responding to requests and explaining procedures as applicable.
  • Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
  • Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
  • Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
  • Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
  • Translates department goals into individual objectives and KPI.
  • Identifies, develops and implements processes to improve department performance.
  • Monitors departmental activities and records to ensure compliance.
  • Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools.
  • May also direct work assignments for quality control auditors.
  • May also direct Quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & engineers.
  • May own, author, review, approve, and support CAPA activities.
  • Supports, actively engages, and may escort internal and external auditors (BSI, FDA, KGMP, etc).
  • Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
  • Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.


Influence/Leadership:
  • Promotes the attainment of group goals by selecting, motivating, and training capable staff
  • Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives


Planning/Organization:
  • Schedules human and material resources within a group or section in conjunction with near-term plans to ensure their availability
  • Carries out operations within an established budget.


Decision Making/Impact:
  • Assignments are expressed in the form of tasks and objective;
  • Generally makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve site commitments and program objectives established by senior management
  • Consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.


Required Qualifications
  • B.S. in Engineering or related field; or equivalent combination of education and work experience.
  • 8-10 years roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired.
  • 3-5 years in a supervisory/leadership role.
  • Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.
  • Technical/Business Knowledge (Job Skills): Monitors progress of exempt individuals, teams, supervisors or nonexempt technical individuals toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Cognitive Skills: Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned area or related departments; facilitates others involvement in the continuous improvement program; investigates and solves problems that impact work processes and personnel within the assigned unit.
  • Demonstrated and impactful strong project management and people leadership skills required.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multi-tasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.


Preferred Qualifications
  • Class II or III medical device experience or comparable regulated industry strongly preferred.
  • Six Sigma Black Belt strongly preferred.
  • ASQ Certified Quality Engineer strongly preferred.
  • Industry certification preferred.
  • Experience working in a broader enterprise/cross division business unit model preferred.


Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

The base pay for this position is
$99,300.00 - $198,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
SH Structural Heart

LOCATION:
United States > Westfield: 1820 Bastian Court

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 10 % of the Time

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

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Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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