Quality Release Lead — QC Compliance & CAPA (Hybrid)

At Smith+Nebur, we design and manufacture technology that takes the limits off living. The Quality Compliance release team is focused on ensuring that Smith + Nephew complies with key regulatory requirements and procedures associated with the release of manufactured products. This position is responsible for developing, maintaining, and coordinating the compliant release process of finished goods for which Hull are the Legal Manufacturer, ensuring compliance with Company Quality Systems, regulatory and statutory Health & Safety requirements, and Site Safety Policy.

Furthermore, this role is responsible for leading the coordination, development, and training of other QC Release Personnel for compliance against appropriate procedures, along with being considered a subject matter expert in the release controls and process of CMO.

Detailed Responsibilities & Accountabilities:

• To apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.
• To perform all activities in compliance with relevant GMP, GDP, ISO 9001, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices.
• To ensure that all Quality Compliance Release external communications are of an acceptable standard to meet customer needs and facilitate improvement where necessary.
• To provide Quality Compliance Release support to CMO and Hull operations to ensure timely closure of quality activities and drive continual improvements.
• To assist and support the internal audit schedule in accordance with the procedure, to ensure compliance and timely close out of improvement actions.
• To assist in the management of the Company’s Quality Archive Store to ensure continued compliance.
• To support Change Control activities ensuring outputs are correctly translated into procedures and are communicated.
• To collate, interpret and report data from multiple sources to support business reporting activities including the generation of Certificates of Analysis.
• Review goods returned for applicable disposition according to local procedural requirements.
• To input and manage data within existing Quality System databases.
• To present Quality system processes as SME and provide data to external regulatory bodies and senior management as required.
• To ensure efficient and effective Quality Compliance Release processes are operating site wide through the development and implementation of procedures, training, and guidance.
• To lead and coordinate NCs and Corrective Action & Preventative Action (CAPA) relating to function.
• Escalate adverse trends and ensure all specified actions are closed in a timely manner within the Quality Systems team.
• To provide Quality Compliance support to Operations / Project Teams to ensure that changes are controlled within defined Quality Systems and meet customer needs.
• To assist as required in the creation and management of departmental measures which monitor section performance and drive continuous improvement.
• Assist, where necessary, in any potential or actual Field Safety Corrective Actions.
• To manage workload effectively to achieve personal and departmental objectives, and support other QC personnel with theirs.
• To provide an efficient and timely service to meet business requirements.
• To analyse data and establish conclusions based on available information.
• To lead, mentor and support the training and development of Quality Compliance Release personnel accordingly.
• To support the establishment and maintenance of appropriate documentation to support Quality Compliance Release requirements in alignment with global and local procedural requirements.
• To support internal and external audits as required.
• To support the identification and execution of continuous improvement initiatives and projects for the Quality Compliance Release process.
• Develop and manage relationships with personnel in all applicable functions and levels to ensure the delivery of the highest standards of internal and external customer satisfaction.

What will you need to be successful?

• Typically educated to degree level or has equivalent work experience in relevant area.
• Advanced working knowledge of company products, processes, procedures, and personnel specifically associated with the QC release process.
• At least 5 years’ experience working within Quality Assurance, preferably within Medical Device / Pharmaceutical Industry.
• Good working understanding of the Medical Device Directive, GxP, ISO 9001, ISO 13485, 21 CFR Part 820.
• Strong analytical and good communication skills are essential together with the ability to manage personal and colleague workload to ensure high standards are maintained.
• Good understanding of the impact of the department on the business.
• Knowledge of the potential for product liability, alleged adverse incidents and potential Field Safety Actions.
• Proficient in Microsoft Systems, specifically Word and Excel, with good written (English) skills required.
• Experience with MS Excel, Word, Outlook, Visio.
• Advanced understanding of the Smartsolve and SAP user systems, including experience in UAT testing and system design requirements.

Benefits:

• Generous annual bonus and pension schemes.
• Save As You Earn share options.
• Private health and dental plans.
• Healthcare cash plans, income protection, and life assurance.
• Hybrid working model.
• Salary sacrifice bicycle and car schemes.

Smith+Nebur is a global medical technology company. We design and manufacture technology that takes the limits off living. We are an equal opportunity employer.