Quality jobs in India
Senior Quality Assurance Engineer
OSI Systems
Quality Lab Team Lead - Food
Kerry
Quality Technician - Space Imaging (Contract)
CBSbutler Holdings Limited trading as CBSbutler
Quality Assurance - QC Inspector 1st shift
ZipRecruiter
Quality Technician
Cameron James Professional Recruitment
Supplier Quality Engineer
E3 Recruitment
Quality Control Technician
First Call Contract Services
Vice President – Quality Assurance Trade Surveillance
BNY Mellon
Connect with headhunters to apply for similar jobsQuality Systems Technologist
Kandhu Recruitment Ltd
Quality Technologist
HUNTER SELECTION
Quality Control Engineer
The West Group Ltd
Quality Assurance Assessor
Lookers Plc
Principal Electrical Supplier Quality Engineer
ZipRecruiter
Quality Control (QC) - Inspector (Coatings) Level 3
J&T Business Consulting
Systems of Quality Management - Senior Manager
ZipRecruiter
Senior Quality Engineer
ZipRecruiter
Circuit Board Quality Assurance Inspector
ZipRecruiter
Quality Technician
Cameron James Professional Recruitment
Quality Assurance
Aloha Vision Consultants
Quality Coordinator. Job in Yorkshire Education & Training Jobs
Construction Skills People
Quality Manager - Technician - Inspector (NR)
Quirónprevención
Quality Lineside Engineer
Guidant Global
Senior Quality Assurance Engineer
Job summary
A leading healthcare technology company is seeking a Senior Quality Assurance Engineer in Edinburgh. The role involves leading QMS performance and ensuring compliance with regulatory standards for medical devices. Candidates should have over 7 years in Quality or Engineering roles, with strong experience in medical device QMS environments. Excellent communication and organizational skills are essential.
Qualifications
- 7+ years in Quality or Engineering roles.
- 5+ years in medical device regulatory and QMS environments.
- Strong knowledge of technical documentation and change control.
Responsibilities
- Lead internal audits and CAPA activities.
- Monitor product performance and address defects.
- Approve Device History Records for compliance.
Skills
Education
At Spacelabs Healthcare, we’re committed to transforming healthcare through continuous innovation. Our scalable solutions deliver critical patient data across local and remote systems, empowering better decisions, improving efficiency, and enhancing patient safety.
We’re seeking a Senior Quality Assurance Engineer to lead and support Quality Management System (QMS) performance across design, manufacturing, service, and compliance functions. This role is pivotal in ensuring our medical devices are safe, effective, and compliant with global standards.
Design Control & Product Development
- Mentor design teams on Design Controls, Risk Management, and Electrical Safety.
- Review Engineering Change Orders for sound engineering practices and compliance.
- Support technical documentation including Essential Requirements Checklists and Risk Management Files.
- Collaborate with engineering on regulatory submissions and design planning.
Manufacturing & Process Improvement
- Oversee manufacturing processes, work instructions, and inspection protocols.
- Approve Device History Records to ensure compliance with Device Master Record requirements.
- Conduct 7S-based floor walkthroughs to drive operational improvements.
Post-Market Surveillance & Service
- Monitor product performance and service documentation.
- Escalate and address defects, assess trends, and identify improvement opportunities.
Quality System Administration
- Lead internal audits, CAPA, process change control, and supplier quality activities.
- Maintain compliance with ISO 13485, MDR/MDD, MDSAP, and other global standards.
- Support regulatory filings including 510(k), CE Mark, and IDE submissions.
Material Review Board (MRB)
- Facilitate efficient processing of Nonconforming Material Reports and Rework Orders.
- Track and report MRB metrics to minimize backlog and improve throughput.
- Bachelor’s degree in Engineering, Quality, or related field (e.g., Biomedical, Electrical, Software).
- 7+ years in Quality or Engineering roles.
- 5+ years in medical device regulatory and QMS environments.
- Experience with SaMD or embedded software in medical devices.
- Strong knowledge of technical documentation and change control.
- Proficient in statistical analysis and risk-based QMS activities.
- Excellent communication skills and a proactive, organized approach.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.
job faster
Follow us
