Senior Quality Assurance EngineerSpacelabs Healthcare • Edinburgh, Scotland, United Kingdom
Senior Quality Assurance Engineer
Spacelabs Healthcare
- Edinburgh, Scotland, United Kingdom
- Edinburgh, Scotland, United Kingdom
À propos
Role Overview 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.
Responsibilities
Design Control: provide Quality System Design Control mentoring to ensure product design teams’ use of critical thinking; ensure activities are completed timely, documented correctly, and compliant with Design Controls, Risk Management, Electrical Safety, and related processes and records. Review Engineering Change Orders and proposed changes to ensure sound engineering practice, effective design, product safety, and QMS compliance; ensure timely product Design Change activities.
Manufacturing: monitor and ensure efficient and effective product manufacturing processes; facilitate manufacturing work instructions, material control, nonconforming material handling, inspection, and finished goods handling.
Material Review Board: facilitate nonconforming material processing and Rework Orders; capture, monitor, and report process performance metrics to minimize quarantine backlog.
Installation and Service: ensure post-market activities support intended device performance; document service and support activities; escalate defects and assess product performance and trends to drive improvement opportunities.
QMS Administration: conduct internal quality audits, corrective and preventive action, process change control, exception handling, process improvement and maintenance, supplier quality, external audit support, and related activities; follow RA/QA management guidance and support other functions in meeting quality objectives and customer requirements. Maintain ISO 13485, European MDD/MDR, and MDSAP compliance; support regulatory submissions as needed.
Additional responsibilities include: ensuring QMS activities are risk-based; supporting internal and third-party audits; driving continual improvement; supporting development teams; maintaining essential safety documentation and regulatory compliance; providing guidance to product design teams on Design Controls, Risk Management, and related records; collaborating with engineering on regulatory submissions; reviewing change requests and orders; maintaining change management tools (CARs, PARs, PCOs); reviewing DHR deliverables; conducting 7S-based manufacturing floor walkthroughs; managing Nonconforming Material Reports and Rework Orders; creating and updating quality system procedures; reporting quality issues and implementing corrective actions.
Qualifications
Bachelor’s degree in a Quality, Engineering, or related discipline (Computer/Software, Biomedical, Mechanical, Electrical).
7+ years related Quality / Engineering work experience.
5+ years of experience with medical device regulatory and quality systems.
Experience maintaining Technical Files, GSRPCs, Risk Management Files, Usability Engineering Files, Design History Files, MVPs, and Change Control documentation.
Experience with statistical analysis.
Knowledge of Software as a Medical Device (SaMD) or software within a device required.
Experience working with teams under design controls and during new product development to follow the QMS and comply with current regulations and standards.
Proven ability to communicate effectively with staff at all levels of the organization.
Self-motivated and organized.
NOTICE TO THIRD PARTY AGENCIES: OSI Systems, Inc. and its subsidiaries do not accept unsolicited resumes from recruiters or employment agencies. If any person or entity submits information without a signed agreement, OSI reserves the right to use such information and pursue and/or hire candidates without financial obligation. Unsolicited information or resumes submitted to hiring managers are considered property of OSI. OSI Systems, Inc. has three operating divisions: Security, Healthcare, and Optoelectronics and Manufacturing.
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Compétences linguistiques
- English
Avis aux utilisateurs
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