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    Supplier Quality Manager - Greer, United States - North American Rescue

    North American Rescue
    North American Rescue Greer, United States

    2 weeks ago

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    Description

    Represents the Regulatory Affairs and Quality Assurance department as the employee responsible for Supplier Management and Sterility. Ensures compliance with state and/or global medical device, pharmaceutical, and cosmetic regulations, as assigned, and overall regulatory department objectives. Provides leadership and direction in the implementation and execution of Quality Systems as related to Suppliers.

    Essential Job Functions

    Development, implementation, and maintenance of systems to assure supplier FDA and EN ISO 13485:2016 compliance.

    Provide leadership in the implementation and execution of Supplier Quality Management activities such as CAPAs, management review trending of supplier performance, supplier related non-conformances, audit results, annual report cards, etc.

    Optimize quality systems to effectively identify measures and reduce cost of quality activities, where applicable.

    Review and approve new suppliers based on risks and Quality System requirements.

    Review and approve supplier changes to product, processes, and materials.

    Coordinate annal supplier review and performance tracking processes.

    Conduct supplier audits, risk assessments, surveys, and performance reviews.

    Manages sterility programs such as annual validations, quarterly dose audits, etc.

    Applies problem-solving skills to the corrective and preventative action (CAPA) process to eliminate problem root cause(s).

    Performs other duties assigned by supervisor.

    Basic Qualifications

    Working knowledge of US FDA and International regulations governing the medical device industry (i.e. QSR, GMP, MDR, and ISO

    Knowledge of fundamental quality systems principles such as CAPA, Failure Investigation and Management Reviews

    Excellent interpersonal skills including the ability to interface and communicate effectively at all levels, both inside and outside the organization

    Demonstrated ability to plan and manage multiple projects, including the ability to manage the resolution of technical and tactical issues

    Demonstrated ability to understand, apply and analyze statistical controls, process validation and controls, and Inspection and Testing Methods validations

    Must have good communication skills both, oral and written

    Team work oriented

    QUALIFICATIONS Education/Experience

    Minimum of a four year degree in the work related sciences (Mechanical engineering, Science or other technical field).

    Minimum of 2 years experience in a federally regulated industry to include Quality Assurance and/or Regulatory Affairs.

    Competencies

    Ability to identify and resolve problems

    Consistently applies excellent communication skills; both oral and written

    Ability to actively listen and display professionalism at all times

    Attention to quality and detail

    Solid organizational skills

    Ability to manage multiple priorities

    Ability to work with limited direction and supervision

    Builds and maintains effective working relationships

    Supervisory Responsibility This position has no supervisory responsibilities.

    Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

    Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

    While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

    Position Type/Expected Hours of Work This is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. Some flexibility in hours is allowed, but the employee must be available during the core work hours and must work 40 hours each week. Occasional evening and weekend work may be required as job duties demand.

    Travel Travel is expected for this position.

    AAP/EEO Statement North American Rescue provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Further, the company takes affirmative action to ensure that applicants are employed and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated.


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