Quality Engineer I

Fusion Life Sciences; Andaman and Nicobar Islands; Remote; INR 1,200,000 - 2,000,000; Full time

Job summary

Fusion Life Sciences is seeking a Senior Quality Systems Specialist to maintain site quality programs and ensure compliance with domestic and international medical device regulations. The role focuses on developing and implementing quality management processes, supporting management, and coordinating cross-site documentation and audits.

You will lead improvements, manage CAPA-related activities, and ensure adherence to GMP, ISO, CMDR, and EUMDR standards across sites.

Qualifications

• Bachelor's Degree and 4 years of relevant experience, or Associate's Degree and 6 years of relevant experience, or High School Diploma or Equivalent and 8 years of relevant experience.
• Bachelor's Degree in life sciences field with minimum 5 years of relevant work experience preferred.

Responsibilities

• Maintain Site Quality programs to ensure compliance with domestic and international medical device regulations.
• Develop and implement processes, procedures, and instruction to sustain and improve the Quality Management System.
• Support Top Management in the development and implementation of quality systems strategies and objectives.
• Oversee and coordinate the communication and release of corporate documents for all sites.
• Develop and support site document control procedures and work instructions.
• Develop and execute process improvements to ensure Site Quality processes meet users' needs and requirements.
• Coordinate project work related to integration of sites and migration to integrated systems.
• Assist and lead audits and assessments, both internal and external, to demonstrate compliance with GMP, ISO, CMDR, and EUMDR regulations.
• Support Quality investigations as needed.
• Manage and facilitate external standard assessments.

Skills

FDA regulations knowledge

Statistical analysis

Technical writing

Organizational skills

Problem solving

MS Office

Adobe Acrobat

Power BI

Education

Bachelor's Degree in life sciences

Associate's Degree

High School Diploma or Equivalent

Tools

MS Office

Adobe Acrobat

PowerBI

Job description

Job Title: Senior Quality Systems Specialist
Remote
Grade: Z11
Job Function: Quality Systems
Sub-Function: Quality

Job Summary

Maintain Site Quality programs to ensure compliance with domestic and international medical device
regulations.

Principal Duties and Responsibilities

• Develop and implement processes, procedures, and instruction to sustain and improve the Quality Management System.
• Support Top Management in the development and implementation of quality systems strategies and objectives.
• Oversee and coordinate the communication and release of corporate documents for all sites.
• Develop and support site document control procedures and work instructions.
• Develop and execute process improvements to ensure Site Quality processes meet users' needs and requirements.
• Coordinate project work related to integration of sites and migration to integrated systems.
• Assist and lead audits and assessments, both internal and external, to demonstrate compliance with GMP, ISO, CMDR, and EUMDR regulations.
• Support Quality investigations as needed.
• Manage and facilitate external standard assessments.
• This is not an exhaustive list of duties or functions and might not necessarily comprise all the essential
  functions.

Expected Areas of Competence (Knowledge, Skills, and Abilities)

• Excellent working knowledge of current USA Food and Drug Administration (FDA) and global laws,
  regulations, and standards
• Familiarity with statistical data analysis tools and concepts
• Ability to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain
  a congenial relationship
• Proficiency in technical writing
• Outstanding organizational skills
• Basic experience or knowledge on issue resolution disciplines (e.g. problem solving/decision making,
  root cause analysis, etc.).
• Must be able to manage stressful situations and to handle controversial issues.
• Must be familiar with all aspects and elements of a quality system including but not limited to corrective
  and preventive action (CAPA), management responsibility, product realization and measurement,
  analysis and improvement processes.
• Highly compliance-oriented to firmly adhere to the principles of the regulations and standards.
• High attention to detail.
• Demonstrated proficiency with MS Office suite, Adobe Acrobat, PowerBI and various data sources.

Education/ Experience Requirements

Bachelor's Degree and 4 years of relevant experience, or Associate's Degree and 6 years of relevant
experience, or High School Diploma or Equivalent and 8 years of relevant experience.

Bachelor's Degree in life sciences field with minimum 5 years of relevant work experience preferred.

Travel Requirements

N/A