Primary Function: Responsible for the coordination of the activities required to meet quality requirements/standards ensuring the Quality System is functioning properly, including administration of the electronic Quality Management System (QMS).

Essential Duties and Responsibilities:

• Oversee the Foster Internal Audit System, including: the development and maintenance of the internal audit schedule and risk assessment, performing internal audits, and assisting with corrective action plans.
• Administer the electronic document control and training systems including: revising documents, approving new or updated documents, maintaining hardcopy archives where required, and maintaining current revision external standards.
• Complete customer surveys, working with other departments when necessary.
• Develop, implement, and maintain quality systems, policies and procedures that ensure compliance of the organization to ISO 13485, and GMP / FDA regulations (as applicable).
• Keeps up to date with developments and requirements of ISO, GMP / FDA (as appropriate) .
• Support continual improvements of the QMS, ensuring that evidence of Corrective and Preventive Actions (CAPA) taken are recorded and reviewed for effectiveness.
• CAPA ownership as assigned.
• Promote quality achievement and performance improvement throughout Foster.
• Conduct Quality on-boarding training for new hires.
• Other duties as assigned by Manager.
  
  
  

Additional Duties and Responsibilities:

• Comply with all related company ISO requirements.
• Comply with all safety regulations and apply good judgment in safely performing all tasks.
• Communicate with the customer service manager on all appropriate concerns related to meeting objectives, working conditions, safety, and interpersonal conflicts.
• Other duties as assigned.
  
  
  

Supervisory Responsibilities: None.

Qualifications:

• Attention to detail is crucial in this position
• Familiarity with the tools, concepts and methodologies of quality management
• Strong working knowledge and experience with Quality Systems
• Strong analytical, problem solving, and decision-making skills
• Able to work closely with all other departments within Foster and external customers
• Flexible in handling multiple and changing work assignments
• Self-reliant in determining priorities and setting schedule to meet goals and objectives
  
  
  

Education and/or Experience:

Bachelor’s degree in a business, science, or a technical field with five or more years of relevant experience desired, or at minimum an Associates degree in business, science, or a technical field with up to five years of relevant experience.

Mathematical Skills:

• Ability to work with mathematical concepts and fundamentals of applied statistics
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
  
  
  

Language/Communication Skills:

• Ability to read and interpret documents including safety rules, operational instructions, procedure manuals, and SDS sheets.
• Ability to write detailed procedures and work instructions.
  
  
  

Computer Skills: Must be proficient using system programs such as Microsoft Word, Excel, Visio, and Outlook. Experience in eQMS software CEBOS MQ1 and ETQ are a major plus.

Other Required Ability: Must have good reasoning ability as described below:

• Ability to apply common sense to carry instructions in written, oral, or diagram form.
• Ability to deal with problems involving several variables in standardized situations.
• Ability to perform all duties and responsibilities satisfactorily.
  
  
  

Certificates, Licenses, and/or Registrations:

ASQ (American Society for Quality) certification as an Auditor (CQA), or Engineer (CQE) desired but at a minimum any ASQ (American Society for Quality) certification.

Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

• Ability to frequently lift and/or move up to 10 pounds.
• Ability to work in an office environment and utilize business computers and supporting office equipment.
• Ability to sit or stand for 4 hours at a time.
  
  
  

Work Environment: The work environment characteristics described here are representative of those an employee would encounter while performing the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

• Normal exposure to moderate noise levels.
• General office Environment.
  
  
  

Travel Expectations: Minimal to no travel is needed for this role (<5%) to support audits across facilities.

Telework Conditions: All remote work needs to be pre-approved on a case-by-case basis based on time in position, length of request and performance in role. It is to be the exception as a general rule; the position is in office.

Pathogen Exposure Risk: Very Low.