Senior Manager, Quality Engineering

Senior Manager, Quality Engineering Minnetonka MN

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to :

Career development with an international company where you can grow the career you dream of.

An excellent retirement savings plan with high employer contribution

Tuition reimbursement, the student debt program and education benefit - an affordable and convenient path to getting a bachelor's degree.

A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Minnetonka, MN location in the Electrophysiology business. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

What You'll Work On

Recruits, coaches, and develops organizational talent.

Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

Creates an entrepreneurial environment.

Provides direction and guidance to exempt specialists and / or supervisory staff who exercise significant latitude and independence in their assignments.

May supervise non-exempt employees.

Keeps the organization's vision and values at the forefront of decision making and action.

Demonstrates effective change leadership.

Builds strategic partnerships to further departmental and organizational objectives.

Develops and executes organizational and operational policies that affect one or more groups by utilizing technical / professional knowledge and skills.

Monitors compliance with company policies and procedures (e.g., compliance with FDA, BSI, EEO regulations, etc.).

Makes decisions regarding work processes or operational plans and schedules to achieve department objectives.

Develops, monitors, and appropriately adjusts the annual budget for department(s).

Develops, communicates, and builds consensus for operating goals that are in alignment with the division.

Provides leadership to assigned staff and supervisors by communicating and providing guidance towards achieving department objectives; creates immediate to long-range plans to carry out objectives established by top management; develops and calculates a budget for a department or group to meet organizational goals; forecasts future departmental needs including human and material resources and capital expenditures; recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.

Assignments are expressed in the form of objectives; makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management; consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

Required Qualifications

Bachelors Degree in related field, OR an equivalent combination of education and work experience.

Minimum 9 years of related work experience.

Preferred Qualifications

Masters Degree

Demonstrated ability to understand / familiarity with applicable FDA and TUV regulations, and other relevant clinical / regulatory requirements. Class III or II medical device background in a Quality Leadership role. Quality System Regulations knowledge (ISO 9001, ISO 13485).

Demonstrated ability to create relationships, influence and move critical projects forward in alignment with key stakeholders.

Experience working in a regulated environment required : GMPs, GLP's and GCP's.

Proven project management skills; analytical and highly developed problem-solving skills.

Strong interpersonal skills. Strong leadership skills with demonstrated ability to create momentum and deliver excellent results highly desired. Strong written and oral communication and negotiations skills.

Highly developed problem-solving skills. Top performer in managing multiple tasks and priorities.

Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies. Experience working in a broader enterprise / cross division business unit model preferred.

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.

Ability to travel, including internationally.