Sr Quality Systems Specialist

TekWissen LLC; Visakhapatnam; On-site; INR 6,654,000 - 9,030,000; Full time

Job summary

TekWissen Group is seeking a Senior Quality Systems Specialist for a remote, temporary assignment lasting 8 months. The role focuses on maintaining and improving the Site Quality Management System to ensure compliance with domestic and international medical device regulations.

Responsibilities include developing QMS processes, supporting leadership in quality strategy, document control, audit facilitation, and coordinating cross-site integration efforts.

Qualifications

• Bachelor’s degree with 4+ years relevant experience, or Associates degree with 6 years, or HS diploma with 8 years.
• Bachelor’s degree in life sciences 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 QMS processes, procedures, and instructions to sustain and improve the system.
• Support top management in quality system strategies and objectives.
• Oversee and coordinate release of corporate documents across sites.
• Develop and support site document control procedures and work instructions.
• Drive process improvements to meet user needs and requirements.
• Coordinate site integration and migration to integrated systems.
• Assist and lead audits to demonstrate GMP, ISO, CMDR, and EUMDR compliance.
• Support quality investigations as needed.
• Manage external standard assessments.

Skills

FDA compliance

Statistical data analysis

Technical writing

Organizational skills

CAPA

MS Office

PowerBI

Communication & diplomacy

Education

Bachelor’s degree in life sciences

Associates degree in life sciences

High School Diploma or equivalent

Tools

Adobe Acrobat

PowerBI

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:

Senior Quality Systems Specialist

Location:

Location: Remote
Duration: 8 Months
Job Type: Temporary Assignment
Work Type: Remote

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 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:

• Bachelors Degree and 4 years of relevant experience, or Associates 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.

TekWissen Group is an equal opportunity employer supporting workforce diversity.