Quality Systems Sr Specialist

What You Can Expect

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

How You'll Create Impact

Develop and facilitate Site Management Review Reports and Meetings and Corporate KPI reporting.

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, both internal and external, to demonstrate compliance with GMP, ISO, CMDR, and MDD regulations.

Support coordination of field action activities as needed.

Support Quality investigations.

Manage and facilitate external standard assessments.

Support Annual Product Reviews per established procedure(s).

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

What Makes You Stand Out

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 report 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.

Your Background

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 Expectations

Up to 15% for internal audit.

Expected Compensation Range

$90,000-$110,000

EOE / M / F / Vet / Disability