Vacancy expired!
- Perform routine analytical technical review of project documentation like requirements specifications, verification protocols, plans, traceability reports, risk analysis.
- Work with multiple project teams concurrently
- Ensure document compliance with QSR and procedures.
- Create, review, and update procedures (SOP), work instructions and project document templates
- Participate in improvement of processes.
- Brainstorm ideas to create solutions for identified problems
- Communicate any documentation deficiencies to relevant personnel.
- Interface with clients and draft reports and memos as directed.
- Review and analyze other documentation as required.
- Perform gap analysis of QMS to updated standards as directed
- Perform additional Quality Assurance tasks as directed
- Perform internal audits as directed
- Perform tool validations as directed
- Create training material as directed
- Provide mentorship to junior QA and System Engineers
- Light travel to customer sites (up to 10 days a year)
- BS/MS degree in Engineering, Computer Science, or related subject (or possess the equivalent experience of such a degree)
- 5+ year’s relevant experience within an ISO and FDA compliant Quality Management System is desired.
- 5+ years experience working with Engineering documentation
- 5+ years experience working with technical writing
- Experience in development of work instructions and SOPs is a plus
- Conducting internal quality system audits is a plus
- Applied knowledge of applicable regulatory standards: 21CFR820, ISO 13485, EN 62304, ISO 14971
- Demonstrates good judgment
- Ability to multi-task is essential
- Good verbal, written and interpersonal communication skills
- Good documentation skills and attention to detail
- Excellent analytical skills
- Ability to communicate effectively with all levels of staff and management, both internal and external
- Self-starter with minimal supervision is essential
- Detail oriented
- High level of initiative with ability to self-manage
- Strong interpersonal, communication and organizational skills with ability to work both independently and as part of a team
- Proficiency in computer software: Microsoft Word, Excel, Powerpoint, Visio
- Proficiency in Application Lifecycle Management, Bug tracking tools is a plus
Vacancy expired!