Continuous Improvement Specialist - Quality Systems
KeyMed (Medical & Industrial Equipment) Ltd. (OKM) | Corporate
Type of employment: Permanent employment
Function: Quality / Audit / Corporate Governance
Location: Southend-on-Sea, England, United Kingdom
As a Continuous Improvement Specialist in our Quality Compliance team, you will be responsible for implementing Quality Management System (QMS) improvements that drive efficiency and process optimisation across the UK and Ireland region.
This includes maintaining compliance of processes and procedures in accordance with ISO 13485, ISO 9001, MDSAP and MDR.
Your responsibilities
* Lead and develop continuous improvement activities and strategies for the QMS across all divisions under ISO 13485, ISO 9001, MDSAP and MDR.
* Utilise 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.
* Perform quality systems compliance activities and provide advice to process owners and key stakeholders to ensure procedures, processes, practices and controls are properly developed, implemented and maintained.
* Manage cross-functional project teams to resolve complex quality systems compliance projects, including QMS certification, product registrations, complaint handling, risk assessment, IT systems implementations, and change control.
* 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 as required.
* Manage the Quality Action Plan (QAP) process, ensuring all QAP actions are implemented, verified and closed according to specified timescales while aligning QAP actions to EMEA and Global objectives.
* Follow up on non-conformance reports (both Vendor and Internal) to identify trends and resolve underlying issues within the business.
Minimum Requirements
* Degree-educated in a scientific or technical subject, such as Engineering, Statistics, Microbiology or Software systems development/integration OR demonstrate equivalent experience.
* Certificate in Project Management or equivalent is desirable.
* Previous experience in the Medical Device or Pharma industry is highly advantageous, but we will also consider candidates from highly-regulated manufacturing sectors such as Aerospace, Automotive, Defense, etc.
* Demonstrated relevant experience within Regulatory Affairs, Quality Assurance or R&D concerning quality management systems and/or technical compliance activities.
* Experience with Agile and/or Six Sigma principles.
* Strong skills in writing and developing procedures.
* Advanced proficiency with the Microsoft Office suite, including Word, Excel, Outlook and PowerPoint.
Core Values
* Patient Focus - We put patients at the heart of everything.
* Integrity - We do the right thing.
* Innovation - We look for new ways to make things better.
* Impact - We take accountability and get things done.
* Empathy - We care for one another and work together.
Benefits
* Competitive salary.
* Generous annual leave entitlement.
* Private medical cover.
* Comprehensive company pension scheme.
* Annual health check with BUPA, funded by us.
* Employee Assistance Program to support your health, mental and emotional well-being.
* Subsidised staff restaurant and free parking at HQ.
* Flexible working hours and hybrid remote working options.
* Discounted gym and wellness memberships, cashback and discounts with major UK retailers, and more!
About Olympus Corporate
The Corporate Division is responsible for centralized functions that include Finance and Controlling, HR, IT, Quality Management and Supply Chain Management. It provides essential services and support to all business divisions and is an important project initiator and leader within the international network.
Further information:
Valuing diverse perspectives and lifestyles is closely aligned with our core values. We encourage all candidates to apply, regardless of gender, nationality, ethnic and social origin, religion, age, disability, sexual orientation, marital status, identity or conditions and restrictions which cannot be shown.
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