Infoway Solutions LLC Hiring for QA Documentation Specialist(Medical device) at Remote Full Time

Description:

Start Date: ASAP
End Date: 6 Months From start
Location: REMOTE (Prefer candidates in Eastern Time Zone)

**Other Notes: Highly prefer someone with prior Philips Medical Device experience. **

• Administers a compliant and effective QMS for the activities in scope.
• Enables the transition/deployment of the PQMS and manages its deployment.
• Ensure proper audit planning and schedule meets the requirements of internal policies and external regulations.
• Locally manages plan for all QMS parts in scope while maintaining a compliant and effective (local) QMS throughout the duration of the transition to the PQMS.
• Administers and contributes to the management of any local QMS documents in line with the evolution of the PEQS and PQMS.
• Supports training and training administration as the QMS and contributes to training content for local QMS documents as necessary.
• Contributes to the availability of metrics/KPI data to measure training effectiveness, PQMS deployment and QMS compliance.
• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
• Fully qualified managers who have advanced beyond entry level.
• Has working knowledge of company products and services.
• Frequently interacts with subordinate supervisors and functional peer groups.
• Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules. Works on issues where analysis of situation or data requires review of relevant factors.
• Exercises judgment within defined procedures and policies to determine appropriate action.
• Provides direct supervision to professional individual contributors and/or skilled, support individual contributors (e.g., technicians designers, support personnel).
• Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.
• Reporting Line.
• Report to senior QMS manager or PQMS Manager.

Education and Training : High School diploma.

Experience and Background

• Minimum of three years of similar work experience.
• Experience working in disciplined regulated industry and applying automated technology.
• Experience with business application implementation projects, including experience as an active contributor on projects with scheduled deliverables Familiar with process management methodologies and practices.
• Ensures compliant and effective QMS are established in scope

Position is Remote , CW located on East Coast.
*21 CFR
*ISO 9001
*Medical Device documentation and QA planning (2+ yrs and 4+yrs)

Drug test mandatory ( shouldn’t consume any of the drugs like Amphetamines, Cocaine, Marijuana, and Phencyclidine)

Contact:

Mani – Senior HR Recruiter
Cell: (602) 698-3321
Info Way Solutions LLC

Job Type: Contract

Pay: $32.00 – $35.00 per hour

Benefits:

• Health insurance
• Referral program

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• High school or equivalent (Preferred)

Experience:

• Medical Device documentation: 2 years (Preferred)
• Medical Device: 2 years (Preferred)
• Quality management: 3 years (Preferred)
• QA planning: 2 years (Preferred)
• ISO 9001: 3 years (Preferred)
• 21 CFR: 2 years (Preferred)

Work Location: Remote