[Hiring] Quality Systems Sr Specialist @TekWissen

Role Description

Quality Systems Sr Specialist

Location: Warsaw, IN 46580

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Remote

Shift Timings: Mon - Fri (8:00 AM - 5:00 PM)

• 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.

Qualifications

• 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.

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.

Company Description

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.