What are the responsibilities and job description for the Quality Assurance Specialist position at System One?
Job Title: Quality Assurance Specialist
Location: Mahwah, NJ
Type: Contract
Overview
Global Medical Device company looking to hire experienced QA Specialist to join their growing team!! Must be fluent in English and French. Those that are not will not be considered.
Responsibilities
Requirements
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Location: Mahwah, NJ
Type: Contract
Overview
Global Medical Device company looking to hire experienced QA Specialist to join their growing team!! Must be fluent in English and French. Those that are not will not be considered.
Responsibilities
- Facilitate the change management process for document and product related changes.
- Perform administrative activities related to Stryker’s learning management system.
- Assist with the migration of QMS related documentation from local document management systems to Stryker’s PLM system (Windchill).
- Ensure QMS documentation reflects actual business activities while remaining compliant with applicable internal and external regulatory requirements including but not limited to Site, Division, Corporate, FDA, ISO, MDD, MDR and individual country requirements.
- Drive Good Manufacturing Practices and Good Documentation Practices within Stryker.
- Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS and associated documentation.
- Develop and deliver training for QMS areas of expertise.
- Engage the Stryker IT team in relevant PLM system discussions.
Requirements
- BS in a science, engineering, business or related discipline.
- Minimum of 3 years experience in a regulated industry using electronic document/change management systems preferred.
- Fluent in English and French
- Proficient in Microsoft applications including but not limited to Word, Excel, Power Point, etc.
- Thorough knowledge and understanding of US and International Medical Device Regulations.
- Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
- Ability to plan, organize, and implement multiple concurrent tasks.
- Strong interpersonal skills, written, oral communication and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
- Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
- Demonstrated ability to work in cross-functional team environments.
- Basic understanding of compliance risk situations.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
