Your responsibilities
1. Lead and develop continuous improvement activities and strategies to processes and procedures for the QMS (across all divisions within the business) under ISO 13485, ISO 9001, MDSAP, and MDR.
2. Utilize quality processes and systems such as CAPA, non-conformance reporting, and complaint handling to identify and lead working groups to implement improvement projects within the QMS.
3. Perform quality systems compliance activities and provide advice to process owners and key stakeholders to support them and ensure procedures, processes, practices, and controls are properly developed, implemented, and maintained.
4. Manage cross-functional project teams to resolve complex quality systems compliance projects, which will have a significant impact on the business (e.g., QMS certification, product registrations, complaint handling, risk assessment, IT systems implementations, change control, etc.).
5. Implement and maintain strong project management principles to ensure expected timescales and implementation are completed on time and within budget, presenting progress and status to the senior management team where required.
6. Manage the QAP (Quality Action Plan) process, ensuring all QAP actions are implemented, verified, and closed according to specified timescales while ensuring the QAP actions are aligned with EMEA and Global objectives.
7. Follow up on non-conformance reports (both Vendor and Internal) where appropriate to identify trends and resolve underlying issues within the business.
Your qualifications
1. You should be degree-educated in a scientific or technical subject, such as Engineering, Statistics, Microbiology, or Software systems development/integration OR demonstrate equivalent experience.
2. A certificate in Project Management or equivalent is desirable.
3. Previous experience in the Medical Device or Pharma industry is highly advantageous, but we will also consider highly-regulated manufacturing sectors such as Aerospace, Automotive, Defense, etc.
4. You can demonstrate relevant experience within Regulatory Affairs, Quality Assurance, or R&D concerning quality management systems and/or technical compliance activities.
5. Experience with Agile and/or Six Sigma principles.
6. You have strong skills in writing and developing procedures.
7. Advanced techniques and proficiency with the Microsoft Office suite, including Word, Excel, Outlook, and PowerPoint.
Your competencies
1. Patient Focus - We put patients at the heart of everything.
2. Integrity - We do the right thing.
3. Innovation - We look for new ways to make things better.
4. Impact - We take accountability and get things done.
5. Empathy - We care for one another and work together.
Your benefits
1. In addition to a competitive salary, you will receive a generous annual leave entitlement.
2. You will be eligible to receive private medical cover.
3. Comprehensive company pension scheme.
4. You will receive an annual health check with BUPA, funded by us.
5. Employee Assistance Program to support your health, mental, and emotional well-being.
6. At our HQ, we have a subsidized staff restaurant and free parking.
7. We support work-life balance with flexible working hours and hybrid remote working.
8. Other benefits include discounted gym and wellness memberships, cashback and discounts with major UK retailers, and so much more!
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