Project Engineer (Part Time)
Prime Path Medtech™
- New York, New York, United States
- New York, New York, United States
About
In addition to the regulatory/quality support role, this role will also assist with technical writing and clinical research projects.
POSITION RESPONSIBILITIES
Collaborate with clients and customers on developing and maintaining their quality management systems, SOPs, templates, and style guides based on industry and regulatory standards.
Lead and participate in discussions, manage work product review sessions, and ensure client/customer comments are incorporated.
Ensure work projects are delivered to the highest standard.
Support clients in assigned project meetings and provide daily quality and regulatory guidance to ensure adherence with regulatory requirements as appropriate.
Provide support to currently marketed products as necessary, including reviewing production records and quality system records to maintain compliance with quality and regulatory standards and regulations.
In collaboration with clients and management, evaluate and recommend quality projects to support customers business objectives.
Review and approve various regulatory and quality documents (i.e. technical documents, SOPs, Work Instructions, manuals, design reviews, risk management documentation, complaints, regulatory reporting documents, test protocols and reports).
Work with clients to complete, maintain and document technical data and required quality and regulatory documentation.
Develop, prepare, and submit technical documentation for US and International regulatory submissions.
Execute quality aspects for any field corrective actions as required.
Maintain up-to-date knowledge on domestic and international regulatory and quality requirements, and effectively communicate requirements to project teams and management.
Proactively develop solutions to complex issues.
BASIC QUALIFICATIONS
Bachelor’s Degree in Engineering.
Experience working in a medical field a plus.
Experience writing technical content.
General knowledge with PC and MS Office (Word, Excel, PowerPoint, Outlook, and Adobe Acrobat).
DESIRED/PREFERRED QUALIFICATIONS
Experience as a technical/medical writer.
Experience in medical technology and/or software end user (consumer) documentation.
Experience in producing documents and managing files in a controlled systems environment (workflow, permissions, versions, etc. are system controlled).
Experience in the medical device or pharmaceutical industry.
Aptitude to learn new product technologies, structured process development process.
Excellent written and verbal communication skills.
Self-motivated.
Able to work independently and with teams.
Demonstrated ability to meet deadlines and manage multiple priorities.
Experience with creating and managing project schedules.
PHYSICAL JOB REQUIREMENTS
This role will be part-time ~10 to 15 hours per week.
The role is Remote so while performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
The role will have no travel.
Pay is $25 per hour paid monthly.
Seniority level Entry level
Employment type Part-time
Job function Engineering and Information Technology
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Languages
- English
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