Quality Compliance Associate

Posted 10 Days Ago
Be an Early Applicant
2 Locations
Mid level
Healthtech
The Role
The Quality Compliance Associate coordinates and prepares internal and external audits while ensuring compliance with regulatory standards. The role involves training staff, developing Standard Operating Procedures (SOPs), conducting gap assessments, and implementing corrective actions. This position requires strong communication and problem-solving skills and frequent interaction with regulatory agencies.
Summary Generated by Built In

BASIC FUNCTION:

Performs the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards. Collaborates with clients to develop positive and proactive approaches to regulatory compliance. Participates in training of functional areas and assists in the development of training sessions. Ensures that privacy and security standards are met and adhered to. Coordinates activities and assist with interactions during regulatory agency inspections. Interacts with regulatory agencies on defined matters. Assists with the corrective/preventive actions implementation and documents & data control system

DUTIES AND KEY RESPONSIBILITIES:

  • Assists with the implementing new and revised quality modules and updates standards operating procedures (SOPs).
  • Performs gap assessments to recommend changes to SOPs and ensure compliance with government regulations among functional areas.
  • Monitors and inputs data into electronic audit tracking system for documentation.
  • Participates on functional teams focused on process improvement.
  • Addresses issues, defines and implements effective corrective/preventive actions to adhere to compliance regulations.
  • Supports management in developing, training and conducting procedures for functional areas that comply with government and organizational standards.
  • Performs other relevant duties as assigned.

TYPE AND NATURE OF CONTACTS:

  • Frequent interaction with others within and outside the organization and ability to resolve problem situations with tact.
  • Receives instructions on new assignments
  • Typically reports to a Manager

SUPERVISORY AND BUDGET RESPONSIBILITY:

N/A

WORKING CONDITIONS AND PHYSICAL REQUIREMENTS:

  • Monday through Friday, with a one-hour lunch break each day
  • Working time from 8:00-5:00 p.m. or flexible working hours, as instructed
  • Ability to lift up to 25 pounds (generally less than 5% of work time); occasional exposure to noise, odor and chemicals

KNOWLEDGE SKILL AND ABILITIES:

  • Strong knowledge of quality standards, procedures, and regulations.
  • Excellent oral and written communication skills.
  • Excellent organizational and problem solving skills.
  • Attention to detail and time management skills required.
  • Ability to analyze and interpret data, identify errors and recommend corrective action

MINIMUM QUALIFICATION:

  • Thai National
  • Diploma or Bachelor Degree in any fields
  • Education background in Sciences, Rubber Technology, Engineer, Physics or Chemistry is preferable
  • Minimum 3-5 years working experience in quality management system is preferable
  • Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
  • Must be able to read; write and speak fluent English and Thai.

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.

FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.

FHI 360 will never ask you for your career site username or password, and we will never request money, goods or services during the application, recruitment or employment process. If you have questions or concerns about correspondence from us, please email [email protected].
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

Please click here to continue searching FHI 360's Career Portal.
 

The Company
HQ: Durham, NC
7,642 Employees
On-site Workplace
Year Founded: 1971

What We Do

FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in education, health, nutrition, economic development, civil society, environment, gender, youth, research and technology – creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 70 countries and all U.S. states and territories.

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