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Open nowPosted 84 days ago

Senior Software Quality Engineer

coringroup54 open roles

Where
Corinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK
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Your applicationOpen nowSenior Software Quality Engineercoringroup · Corinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK

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This job: posted 84 days ago

The posting

Senior Software Quality Engineer Corin is seeking an experienced and motivated Senior Software Quality Engineer to support and oversee system and software development activities across our Global Technology Team. This is a critical role within our orthopaedic medical device business, ensuring that software and system development processes comply with FDA, ISO and European Medical Device regulations and standards. You will work closely with Software Development, Product Development, Quality, Regulatory and external suppliers to drive quality excellence throughout the product lifecycle. The successful candidate will play a key role in maintaining and continuously improving software quality processes, supporting compliance to standards such as ISO 13485, ISO 14971 and IEC 62304, while helping to deliver innovative technologies that improve patient outcomes worldwide.

What you’ll do: Software & System Quality Oversight

Provide expert quality assurance guidance and oversight for software and system development activities. Partner with cross-functional global teams throughout the product development lifecycle. Review software project documentation to ensure compliance with regulatory and quality requirements. Participate in design reviews, software and system risk assessments, and project milestone reviews. Collaborate with Software and Product Development teams to define requirements and establish appropriate verification and validation strategies.

Compliance & Quality Systems

Support the application, compliance and continuous improvement of policies, procedures and quality system documentation related to:

Software development and validation Risk management Cybersecurity compliance Software and system verification and validation Quality investigations Requirements traceability

Perform gap assessments of Software Development Lifecycle (SDLC) processes against relevant standards, including IEC 62304 and computer system validation requirements. Develop and implement procedures, controls and quality processes that support a compliant SDLC framework. Promote awareness and understanding of applicable regulatory requirements, quality standards and company procedures across the organization.

Supplier Quality Management

Provide Quality Assurance oversight for software suppliers and service providers. Interface with suppliers to ensure software deliverables and specifications meet defined requirements. Lead supplier audits, assessments and qualification activities for software vendors and service providers.

Quality Improvement & Auditing

Lead and support Corrective and Preventive Actions (CAPA), quality investigations and complaint handling activities. Conduct internal audits of Quality System processes to verify compliance with regulatory requirements and internal procedures. Support external regulatory and certification audits, including preparation, participation and responses to audit findings. Identify and implement improvements to Quality Management System processes and Standard Operating Procedures (SOPs) to ensure ongoing compliance and operational effectiveness.

About You You are a collaborative quality professional with strong experience in medical device software development and quality systems. You have a passion for compliance, continuous improvement and innovation, and are comfortable working across multiple projects in a fast-paced global environment. Essential Knowledge & Skills  

Bachelor's degree in Engineering, Life Sciences, Medical Technology or a related discipline. Minimum of 5–7 years' experience within Quality Assurance, Medical Devices and Software Development environments.

Strong working knowledge of:

ISO 13485 ISO 14971 IEC 62304

Experience supporting product and software development lifecycles. Knowledge of FDA regulations, including:

21 CFR Part 820 21 CFR Part 11 FDA software validation and software development guidance

Ability to manage multiple projects and competing priorities effectively. Strong problem-solving skills and the ability to work independently and collaboratively. Excellent communication, stakeholder management and interpersonal skills. Self-motivated, results-oriented and quality-focused approach. Ability to drive continuous improvement and influence positive change across teams.

Desirable Qualifications & Experience

Trained Internal Quality System Auditor and/or Software Quality Auditor. Experience with Medical Device Regulation (MDR) and MDSAP requirements. Knowledge of:

ISO 27001 ISO 42001 NIST Cybersecurity Framework FDA Pre-Market and Post-Market Cybersecurity Guidance

Experience supporting cybersecurity compliance within regulated medical device environments.

Why Join Corin? Corin is a growing global orthopaedic innovation business, with a vision to revolutionize the field, by integrating advanced robotic and AI technologies (Apollo, OMNIBotics and OPS) for planning, implementation, and continuous learning with its unique combination of clinically proven hip and knee implants. Since its inception nearly 40 years ago, Corin has strived to maximize healthcare value by providing a fast, positive, and assured return to the quality of life for people all over the world. Our revolutionary technologies enable patients, surgeons, and healthcare providers to connect more closely than ever. For further information on who we are, our products and services, please visit www.coringroup.com Our benefits, what’s in it for you:In addition to your salary, support and opportunity to work in a hybrid environment you will also receive

25 days holiday plus bank holidays Excellent pension – starts at 6%, going up to 9.7% after 18 months. Life assurance – Six times your basic salary Private medical insurance with BUPA for you and your family Free annual eye tests and flu vaccinations Employee referral program where you can earn up to £1,000 for each successful hire you recommend

IND007

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