Senior Manager Quality Engineering

The Opportunity

This position works out of our Plymouth, 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.

As the Senior Manager Quality Engineering , you’ll provides leadership and guidance for the quality engineering department supporting commercial products and new product development.

Responsible for developing goals, objectives, procedures, policies, and systems that are in line with company goals and objectives, mission and vision and FDA / ISO regulations.

Assures the overall quality of products meet internal and external customer requirements.

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

Preferred 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.