Life Unlimited. At Smith+Ne`phew we design and manufacture technology that takes the limits off living.
Smith+Ne`phew is hiring QC Release Specialist 2.
The Quality Compliance release team ensures Smith+Ne`phew complies with key regulatory requirements and internal procedures associated with the release of manufactured product. This role 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.
In addition, this role leads the coordination, development, and training of other QC Release Personnel, ensuring compliance with procedures and acting as a subject matter expert in the release controls and processes of CMO.
Detailed Responsibilities & Accountabilities
* Apply high standards of occupational health and safety to comply with company policy and procedures.
* Perform all activities in compliance with GMP, GDP, ISO 9001, ISO 13485, US FDA 21 CFR Part 820 and other applicable quality standards or regulations concerning medicinal products and medical devices.
* Ensure all external communications of the Quality Compliance Release team meet customer needs and facilitate improvement where necessary.
* Provide support to CMO and Hull operations to ensure timely closure of quality activities and drive continual improvements.
* Assist the internal audit schedule in accordance with procedures, ensuring compliance and timely close‑out of improvement actions.
* Manage the company’s quality archive store to maintain compliance.
* Support change‑control activities, ensuring outputs are translated into procedures and communicated.
* Collate, interpret and report data from multiple sources to support business reporting activities, including generation of certificates of analysis.
* Review returned goods for appropriate disposition according to local procedural requirements.
* Input and manage data within existing quality‑system databases.
* Represent quality system processes as an SME and provide data to external regulatory bodies and senior management as required.
* Ensure efficient and effective quality‑compliance release processes operate site‑wide through development and implementation of procedures, training and guidance.
* Lead and coordinate non‑conformances and corrective action & preventive action (CAPA) relating to this function.
* Escalate adverse trends and ensure all specified actions are closed timely within the quality‑systems team.
* Support operations/project teams to ensure changes are controlled within defined quality systems and meet customer needs.
* Assist in creating and managing departmental measures that monitor performance and drive continuous improvement.
* Assist, where necessary, in field safety corrective actions.
* Manage workload effectively to achieve personal and departmental objectives and support other QC personnel.
* Provide an efficient and timely service to meet business requirements.
* Analyse data and establish conclusions based on available information.
* Lead, mentor and support the training and development of quality‑compliance release personnel.
* Support the establishment and maintenance of appropriate documentation for quality‑compliance release requirements in alignment with global and local procedures.
* Support internal and external audits as required.
* Support 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 deliver the highest standards of customer satisfaction.
What Will You Need to Be Successful?
* Typically educated to degree level or has equivalent work experience in a relevant area.
* Advanced working knowledge of company products, processes, procedures and personnel specifically associated with the QC release process.
* At least 5 years’ experience in quality assurance, preferably within the medical device or pharmaceutical industry.
* Good understanding of the Medical Device Directive, GxP, ISO 9001, ISO 13485, 21 CFR Part 820.
* Strong analytical, communication skills and the ability to manage personal and colleague workload to maintain high standards.
* Understanding of the department’s impact on the business.
* Knowledge of potential product liability, adverse incidents and field safety actions.
* Proficient in Microsoft Office (Word, Excel, Outlook, Visio) and good written English skills.
* Advanced understanding of SmartSolve and SAP, including UAT testing and system‑design requirements.
Benefits
Generous annual bonus and pension schemes, Share‑As‑You‑Earn share options.
Flexible vacation and time off, paid holidays and paid volunteering hours.
Private health and dental plans, health‑care cash plans, income protection, life assurance.
Hybrid working model for most professional roles.
Hands‑on, team‑customised mentorship training.
Employee discounts on gyms, fitness clubs and other benefits.
Inclusion and Belonging
Committed to welcoming, celebrating and thriving on inclusion and belonging.
#J-18808-Ljbffr