At a Glance
- Tasks: Ensure quality compliance for medical devices and lead a dynamic QC team.
- Company: Join Smith+Nephew, a leader in innovative healthcare technology.
- Benefits: Enjoy flexible working, generous bonuses, and health perks.
- Other info: Be part of a community that values inclusion and continuous improvement.
- Why this job: Make a real impact on patient lives while growing your career.
- Qualifications: Degree or equivalent experience in Quality Assurance, preferably in medical devices.
The predicted salary is between 40000 - 50000 € per year.
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Smith+Nephew is hiring QC Release Specialist 2. The Quality Compliance release team is focused on ensuring that Smith + Nephew complies with key regulatory requirements and Smith + Nephew procedures associated to the release of manufactured product. 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.
- To 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.
- To 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.
- To 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.
- To 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.
- 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 to 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) skill 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.
Quality Control Release Specialist 2 employer: Smith & Nephew
At Smith+Nephew, we pride ourselves on being an exceptional employer, offering a vibrant work culture that champions inclusion and personal growth. Our Quality Control Release Specialist 2 role not only provides competitive benefits such as generous bonuses, flexible working arrangements, and comprehensive health plans, but also fosters professional development through tailored mentorship and training opportunities. Join us in a collaborative environment where your contributions directly impact the lives of patients and the community.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Control Release Specialist 2
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Smith+Nephew on LinkedIn. Ask them about their experiences and any tips they might have for landing the QC Release Specialist role. Personal connections can give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of quality compliance and regulatory standards. Be ready to discuss how your experience aligns with the responsibilities listed in the job description. Show them you're not just a fit, but the perfect fit!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or family, focusing on common questions related to quality assurance and compliance. This will help you articulate your thoughts clearly and confidently when it’s your turn to shine.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email expressing your appreciation for the opportunity can leave a lasting impression. It shows your enthusiasm for the role and keeps you fresh in their minds.
We think you need these skills to ace Quality Control Release Specialist 2
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in Quality Assurance, especially in the Medical Device or Pharmaceutical industry. We want to see how your skills align with our needs at Smith+Nephew!
Showcase Your Compliance Knowledge:Since this role is all about ensuring compliance with various regulations, be sure to mention your familiarity with GMP, GDP, ISO standards, and any relevant quality systems. We love seeing candidates who understand the importance of these standards!
Highlight Your Analytical Skills:We’re looking for someone with strong analytical abilities, so don’t shy away from sharing examples of how you’ve used data to drive improvements in past roles. Show us how you can contribute to our commitment to quality!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find more info about our culture and values there!
How to prepare for a job interview at Smith & Nephew
✨Know Your Regulations
Familiarise yourself with key regulations like GMP, GDP, ISO 9001, and ISO 13485. Being able to discuss these standards confidently will show that you understand the compliance landscape and can navigate it effectively.
✨Showcase Your Analytical Skills
Prepare examples of how you've used data analysis in previous roles. Discuss specific instances where your analytical skills led to improvements in quality processes or compliance, as this is crucial for the Quality Control Release Specialist role.
✨Demonstrate Leadership Experience
Since this role involves leading and mentoring other QC personnel, be ready to share your experiences in training and developing team members. Highlight any successful initiatives you've led that improved team performance or compliance.
✨Communicate Clearly
Practice articulating your thoughts clearly and concisely. Given the importance of external communications in this role, being able to convey complex information simply will set you apart. Consider mock interviews to refine your communication style.
