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Fresenius Medical Care North America Supervisor, Quality Engineering in Ogden, Utah

Job ID 19000PCV

Available Openings 1

PURPOSE AND SCOPE:

Provide assistance in performing critical thinking, data analysis, risk based prioritization techniques and disciplined problem solving for supplier, customer, and internal quality defects and/or product or process improvement opportunities. Maintains knowledge of all products, processes, and basic quality principles required to assist with daily operations and continual improvement activities. Understands the technical aspects of the company including products and processes in order to drive quality improvements and communicate them clearly to team members, peers, associates and management personnel.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Supervise the daily operations of the team, including but not limited to: establishing personal, team based and / or functional department goals, assigning tasks and maintaining schedules, providing routine follow-up, support and reinforcement, and cultivating an accountable, high performance culture within the team.

  • Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.

  • Ensure all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations; establishing and maintaining effective internal systems and controls to promote compliance.

  • Provide direct supervision of the assigned team(s) through ongoing leadership and guidance; partnering with functional departmental management and Human Resources on employee matters.

  • Technically proficient in areas of assigned responsibility. Demonstrates process proficiency (or strong process aptitude) with respect to NCR, CNCR, CAPA, Change Control and Pharmaceutical Change Control processes.

  • Works on issues where analysis of situation or data requires a review of relevant factors. Exercises judgment within defined procedures and policies to determine appropriate action. Role primarily focuses on tactical execution.

  • Receives assignments in the form of objectives with goals and the process by which to meet the goals. Management reviews work to measure meeting of objectives.

  • Provides direction to employees, according to established policies, procedures and management guidance. Supervises day-to-day operations of employees. Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.

  • Administers company policies, processes and procedures that directly affect subordinate employees and the workflow unit. Recommends changes to unit or sub-unit policies.

  • Decisions impact work unit operations; usually limited to “how to” execute within defined processes.

  • Frequently interacts internally with subordinates and other supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules and basic problem resolution.

  • External interaction is typically with suppliers, vendors, and/or customers. May work with external companies or vendors to resolve routine problems and/or facilitate work flow.

  • Provide technical guidance.

  • Assist with various projects as assigned by direct supervisor.

  • Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS :

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISION:

Will be responsible for the direct supervision of assigned individuals. This may include personnel from one or more levels including but not limited to QC Inspectors, Device Release Personnel, NCR Technicians, Quality Technicians, Associate Quality Engineers, Quality Engineer 1, and/or Quality Engineer 2.

EDUCATION :

  • Bachelor’s Degree required.

EXPERIENCE AND REQUIRED SKILLS:

  • 3-5 years of experience in a Quality Engineering capacity or similar / related capacity in a Medical Device or Pharmaceutical Manufacturing enterprise is desired.

  • Prior Supervisory experience is desired (but not required).

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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