CQV Engineer
CQV Engineer
Boston / Rhode Island
Responsibilities :
- Draft and implement Quality System documentation designed to establish good validation practices within the organization.
- Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
- Design validation approaches, supported by appropriate statistical analyses, perform and / or coordinate all validation activities, analyze and assemble results, and draft validation reports.
- Provide input on user and / or functional requirements of current and future processing equipment, and draft appropriate documentation.
Additionally, interface with Contract Manufacturers to ensure all relevant user and functional requirements are met.
- Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
- Execute assigned duties on time and pro-actively telegraph delays and other issues to validation manager and other relevant stakeholders.
- Comply with all regulatory, corporate, and Quality System policies
Qualifications :
- B.S. / M.S. in engineering or another relevant discipline.
- Minimum of 5+ years of experience working within a medical device environment or other FDA regulated environments. Experience with device-biologic combination products is highly desirable.
- Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.
Quality Systems (Change Control, Non-Conformances, Requalification, etc)
- Working knowledge of Computer Systems Validation lifecycle and documentation.
- Proficient in Microsoft Word, Excel, PowerPoint.
- Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
- Must demonstrate strong communication, interpersonal and teamwork skills.
- A strong understanding of technical writing and presentation skills is required.
Sr. Mechanical Engineer - Security Clearance Required
Mechanical Engineer (Contract/Temp). Advanced proficiency with modeling CAD tools to create mechanical models and drawings. Design of electro-mechanical systems capable of surviving harsh environmental conditions (shock, vibration, temperature). ...
Quality Engineer - Manufacturing
The Quality Engineer participates in the development, execution, and oversite of products and processes used in the manufacturing environment to ensure robust and cost-effective designs. ...
Entry-Level Civil Engineer - Land Development (Hybrid Opportunity)
We are seeking an entry-level. Under the general direction of senior engineers and project managers, this professional will support all aspects of land development engineering projects. Bachelor's degree in Civil Engineering. Fuss & O'Neill is a civil and environmental engineering firm that provides...
Design Engineer
JobPosting","title":"Design Engineer","datePosted":"2024-08-29T00:00:00","validThrough":null,"description":"How You'll Make a Difference\nYou will bridge the gap between design and engineering, ensuring that world-class user experiences are brought to life through seamless execution. You will bridge...
Quality Engineer
The Quality Engineer participates in the de. ...
Mechanical Engineer II
Bachelor's degree in Mechanical Engineering or related technical discipline, with 3-5 years of related experience; with at least 2 years of responsibility managing engineering project work. Oversee assembly of test samples and guide mechanical technicians in the set-up and performance of in-house te...
Process Engineer, Staff-Textiles
Process Development Engineer, Staff reporting to Manager, Engineering,. BS or MS in Mechanical Engineering, Textile Engineering, Biomedical Engineering, or equivalent. Work as technical lead on development programs, under the direction of the textile development engineering manager and cross-functio...
Specialist Computer Systems Validation Engineer
Specialist Computer Systems Validation Engineer. Lead computer validation testing initiates with oversight of project resources and analysis of test results and preparation of summaries. Masters degree and 3 years of Information Systems or Engineering experience. Bachelors degree and 5 years of Info...
Program Manager - Access Services
This includes overseeing and managing the day-to-day functions and staff in the program. Provide clinical supervision to Access staff including, Assessment Clinicians, Case Managers, Benefit Specialist and Peer Specialist, covering positions as needed. Develop relationships with Thrive CCBHC's DCOs ...
Transportation Project Engineer
Transportation Project Engineer. This position will also collaborate across our multiple service areas, assist with business development, project pursuits, and coordinate projects with our clients. New England based consultant engineering firm and leader in the fields of transportation, traffic, str...