LifeSprout, Inc. · Baltimore, MD · Just now · 0 applicants
NewOn-siteContractSenior
Pay
Pay not listed
Workplace
On-site
Job type
Contract
Level
Senior
Team: Quality · Source: jobright · Posted by joined-scrapper
About the role
LifeSprout is hiring a contract Quality Engineer to support quality management, regulatory compliance, and medical-device operations at its Baltimore facility. The role involves executing QMS processes, collaborating with cross-functional teams and suppliers, and supporting validation, investigations, and audits.
What you’ll do
Maintain and execute the Quality Management System
Support quality and regulatory compliance activities
Collaborate with cross-functional teams and suppliers
Review validation protocols, investigations, technical reports, or manufacturing records
Support risk-based product, material, equipment, or facility disposition
Support regulatory, notified-body, certification-body, or supplier audits
What you’ll need
Bachelor's degree in engineering, life sciences, or a relevant scientific/technical discipline
At least 5 years of Quality Assurance or Quality Engineering experience in a regulated life-sciences industry
Hands-on experience with ISO 13485 and FDA medical-device Quality System requirements
Working knowledge of QMS processes including CAPA, deviations, nonconformances, change control, document control, training, audits, and supplier quality
Experience reviewing validation protocols, investigations, technical reports, or manufacturing records and independently managing deliverables
Eligibility to work in the United States and strong technical writing, communication, organization, and problem-solving skills
Original job description
LifeSprout, Inc. is hiring a Contract Quality Engineer to support its medical-device development, manufacturing, and related operations at its Baltimore facility. The role helps maintain and execute the Quality Management System, supports quality and regulatory compliance activities, and collaborates with cross-functional teams and suppliers.Bachelor's…