Centraprise · 4 days ago
NPD Quality Engineer
Plymouth, MN
Full-time
Onsite
Mid LevelCentraprise is focused on quality management in the medical device sector, and they are seeking a NPD Quality Engineer to ensure compliance with regulatory standards and improve product quality. The role involves utilizing various quality management tools and techniques, as well as writing procedures and reports related to quality assurance.
EmploymentRecruitingStaffing Agency
Hiring Manager
Anshul Kumar
Responsibilities
Knowledge on Quality Management and its tools & techniques
Knowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulations
Knowledge on Medical Device Regulatory Standards, MDD and MDR
Knowledge on NC, CAPA, Root Cause Analysis and Audit processes
Knowledge on Validation process, writing protocols/ reports
Very good understanding/ experience in writing procedures, product specs and work instructions
Knowledge in Statistics, Risk Management and Design control
Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills
Experience in creating FMEAs & Writing reports
Experience in PMS (Post Market Surveillance)
Experience in PLM Tool (Windchill)
Good understanding of Design, Drawing and GD&T
Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)
Qualification
Required
Knowledge on Quality Management and its tools & techniques
Knowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulations
Knowledge on Medical Device Regulatory Standards, MDD and MDR
Knowledge on NC, CAPA, Root Cause Analysis and Audit processes
Knowledge on Validation process, writing protocols/ reports
Very good understanding/ experience in writing procedures, product specs and work instructions
Knowledge in Statistics, Risk Management and Design control
Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills
Experience in creating FMEAs & Writing reports
Experience in PMS (Post Market Surveillance)
Experience in PLM Tool (Windchill)
Good understanding of Design, Drawing and GD&T
Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)
Company
Centraprise
Centraprise is an executive search and direct hire company.
Founded in 2010
501-1000 employees
H1B Sponsorship
Centraprise has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (16)
2023 (49)
2022 (35)
2021 (42)
2020 (125)
Funding
Current Stage
Late StageLeadership Team
Praveen Mummaneni
Chief Executive Officer
Anand Bandarupally
Managing Partner - Developing Recruitment and Business Development
Company data provided by crunchbase