Quality Systems Sr Specialist

TekWissen LLC; Visakhapatnam; On-site; INR 8,555,000 - 11,407,000; Part time

Job summary

TekWissen LLC seeks a Quality Systems Sr Specialist to lead QMS processes and regulatory compliance initiatives. The role emphasizes SOP development, document control, and interface with top management on quality strategy.

The position is remote, with responsibilities spanning multiple sites to ensure GMP, ISO, and EUMDR compliance while driving continuous improvement.

Qualifications

• Experience with Quality Management Systems (QMS) and regulatory compliance.
• Ability to implement, maintain, and improve CAPA processes.
• Experience coordinating audits and regulatory inspections.

Responsibilities

• Develop and implement processes to sustain and improve QMS.
• Support top management with quality systems strategies and objectives.
• Oversee communication and release of corporate documents for sites.

Skills

Quality Systems

GMP/ISO

CAPA

FDA knowledge

Technical writing

Data analysis

Power BI

Document control

Education

Bachelor's Degree in Life Sciences

Tools

Microsoft Office

Adobe Acrobat

Power BI

Job description

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. Client has operations in more than 40 countries around the world.

Job Title: Quality Systems Sr Specialist
Location: Remote
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Remote
Shift Timings: Mon - Fri (8:00 AM - 5:00 PM)

Responsibilities

• Develop and implement processes, procedures, and instructions 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 standards assessments.
• Perform additional quality system and compliance-related activities as required.

Required Skills

• Excellent working knowledge of current U.S. Food and Drug Administration (FDA) and global laws, regulations, and standards, particularly EUMDR.
• Familiarity with statistical data analysis tools and concepts.
• Ability to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain congenial relationships.
• Proficiency in technical writing.
• Outstanding organizational skills.
• Basic experience or knowledge of issue resolution disciplines such as problem solving, decision making, and root cause analysis.
• Ability to manage stressful situations and handle controversial issues effectively.
• Familiarity with all aspects and elements of a Quality Management System, including:
  • Corrective and Preventive Action (CAPA).
  • Management Responsibility.
  • Product Realization.
  • Measurement, Analysis, and Improvement Processes.
• Highly compliance-oriented with a strong commitment to regulatory and quality standards.
• High attention to detail.
• Demonstrated proficiency with:
  • Microsoft Office Suite.
  • Adobe Acrobat.
  • Power BI.
  • Various enterprise 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.

Preferred Education & Experience

• Bachelor s Degree in a Life Sciences field.
• Minimum of 5 years of relevant quality systems, compliance, or regulatory experience.

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.