Abbott

Manager, Design Assurance

Abbott • $99K — $198K *
Minnetonka, MN 55345In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Associates Degree or equivalent experience (approx. 13 years).
  • Minimum 7 years of relevant industry experience.
  • Demonstrated experience in quality assurance programs in medical device development.
  • Strong leadership skills to manage Quality Engineering teams
  • Knowledge of ISO 13485 and US QMSR regulations.

Responsibilities

  • Lead design quality engineering for medical device development.
  • Manage and develop Quality Engineers and Technicians.
  • Identify compliance opportunities with internal and international quality regulations.
  • Define and implement design control parameters across product lines.
  • Drive quality improvements in partnership with international teams.
  • Lead cross-functional teams on quality initiatives.
  • Communicate quality metrics and performance improvements to management.

Benefits

  • Opportunities for continuous improvement initiatives.
  • Support for professional development and regulatory compliance training.
  • Engagement in cross-functional teamwork across departments.
Full Job Description
JOB DESCRIPTION:

Main Purpose of the Role

This position is responsible for providing design assurance leadership for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.

MAIN RESPONSIBILITIES
  • Provide design quality engineering leadership in direct support of medical device development, including: Management and development of Quality Engineers and Technicians, and Manage the activities of the design Quality Engineering team.
  • Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.
  • Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US QMSR, ISO 13485, etc.
  • Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
  • Define and implement critical parameter for design control and related systems throughout the product lines.
  • Provide influential peer leadership with international partner site to drive proactive quality improvements.
  • Identify Quality Initiatives and lead cross-functional teams to complete them.
  • Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.
  • Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
  • Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
  • Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
  • Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization.
  • Manage the activities of the Pre-Production Quality Engineering team for new product introduction and sustaining activities
  • May direct the development; implementation and maintenance of the risk management process in the Quality System across product realization by providing strategic and tactical direction.
  • May determine the changes; improvements and investments needed to support the risk management process in the Quality System and business driven objectives and to leverage new and evolving regulatory guidance.
  • May develop best practices to aid in the implementation of risk management requirements. May provide guidance to product teams regarding risk identification; assessment; control and communication.
  • May maintain the dFMEA and Control Plan templates as well as the Best Practice documents.


QUALIFICATIONS

Education

Associates Degree (± 13 years)

Experience / Background

Minimum 7 years

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:
Engineering

DIVISION:
CRM Cardiac Rhythm Management

LOCATION:
United States > Minnesota > Minnetonka : 14900 Minnetonka Industrial Road

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
No

MEDICAL SURVEILLANCE:
Yes

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment

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.

Stay Connected

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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