Senior Software Quality Engineer
Colonial Group
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Benefits offered by this job
Job summary
Corin Group is seeking a Senior Software Quality Engineer to oversee software and system development activities across its Global Technology Team. You will ensure compliance with FDA, ISO, and European Medical Device standards and drive quality improvements across multiple projects in a fast-paced environment.
The role involves risk assessments, validation strategies, supplier quality oversight, and supporting regulatory audits in a hybrid work setting in the UK.
Qualifications
- Bachelor's degree in Engineering, Life Sciences, Medical Technology or related discipline.
- Minimum 5–7 years’ experience within Quality Assurance, Medical Devices and Software Development environments.
- Experience with regulatory standards and medical device software quality systems.
Responsibilities
- Provide expert quality assurance guidance for software and system development activities.
- Partner with cross-functional global teams across the product lifecycle.
- Review software project documentation to ensure regulatory and quality compliance.
- Lead audits, CAPA, and continuous improvement of quality systems.
- Support cybersecurity compliance and regulatory audits.
Skills
Education
Tools
Job description
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.
- 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.
- 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.
- 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.
- 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.
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.
- 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.
- 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.
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
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
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