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Abbott · 8 hours ago

Senior Manager, Quality Engineering

Minnetonka, MN

Full-time

Onsite

Senior Level, Lead/Staff

$129K/yr - $259K/yr

9+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Senior Manager Quality Engineering will provide leadership and guidance for the quality engineering department, ensuring that products meet customer requirements and comply with FDA/ISO regulations.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

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

Qualification

Quality EngineeringFDA regulationsISO 13485GMPsGLPsGCPsProject ManagementLeadershipInterpersonal SkillsCommunication SkillsProblem-SolvingOrganizational Skills

Required

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

Minimum 9 years of related work experience

Preferred

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