Essential Duties and Responsibilities:

• Perform routine analytical technical review of project documentation
• Work with multiple project teams concurrently
• Create, review, and update documentation.
• Ensure document compliance with QSR and procedures.
• Create, review, and update procedures (SOP), work instructions
• Participate in improvement of processes.
• Communicate any deficiencies in GMP, safety or systems to relevant personnel.
• Interface with clients and draft reports and memos as directed.
• Review and analyze other materials as required.
• Perform additional Quality Assurance tasks as directed
• Perform internal audits as directed

Education and Experience:

• BS/MS degree in Engineering, Computer Science, or related subject (or possess the equivalent experience of such a degree)
• Two year’s relevant experience is desired.
• Detail oriented
• Solid interpersonal, communication and organizational skills
• Ability to multi-task is essential.
• Proficiency in Microsoft Office
• Demonstrates good judgment.
• Experience in Medical Device Development is a plus

Knowledge and Skills:

• 5+ years experience working with Engineering documentation
• 5+ years experience working with technical writing
• 3-5 years experience working within an ISO and FDA compliant Quality Management System
• Good verbal, written and interpersonal communication skills
• Good documentation skills and attention to detail
• Good ability to execute test protocols, log and track defects to closure, collaborate with team to resolve
• Good ability to analyze and resolve non-routine product, testing, and/or test equipment/tool issues using independent judgment
• Good ability to develop unit test protocol (not mandatory)
• Excellent analytical skills
• High level of initiative with ability to self-manage
• Strong interpersonal skills with ability to work both independently and as part of a team