Quality Manager Runcorn Runcorn, England
Epredia
Full Time
Runcorn, England
30620 - 48127 GBP ANNUAL Today
Job description
Epredia, a global leader in providing solutions for cancer diagnostics, is dedicated to improving lives by enabling our customers to achieve diagnostic excellence. We’re growing quickly and constantly expanding our team. Find a rewarding career with a diverse group of individuals that share a passion to do work that matters and positively impacts patient lives.
Job Description
Position Summary:
The position will be responsible for driving Quality improvement in products, processes ,compliance and customer satisfaction within the Runcorn facility under the mentorship of the Senior Quality Manager.
Essential Job Functions and Accountabilities which this role will develop into.
QMS Leadership
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Establish, document, implement, maintain, and continuously improve a Quality Management System (QMS) that is compliant with ISO 13485. The QMS includes but is not limited to the following items:
- Root Cause Analysis
- Corrective and Preventive Action
- Document Control
- Change Management
- Supplier Management
- Acceptance Activities including Incoming Inspection, In process, and Finished Product inspections, Device History Records, Non-Conforming Records, and the Quality Hold process
- Internal Audits
- Act as Quality Management Representative for the UK site, and commercial site activities across the EMEA region.
- Report to top management on the performance of the Quality Management System and any need for improvement.
- Ensure the promotion of awareness of customer requirements throughout the organization.
- Liaise with external parties on matters relating to the Quality Management System including acting as the Management Representative (MR) for audits.
Quality Measurement, Reporting, and Improvement
- Establish and monitor performance metrics, champion quality and customer focused initiatives.
- Drive reduction of customer complaints using solid investigation methodologies and root cause analysis expertise. Lead problem solving activities and implementation of permanent solutions.
- Utilize in-house and externally obtained data to drive product improvements and reliability.
- Track and monitor key performance indicators and create summary reports for the site and regional metrics.
- Utilizing key process indicators (KPI’s), promote and initiate continuous improvement activities that drive change within the business that result in cost effectiveness, revenue enablement and support overall Epredia objectives.
- Build cross functional team collaborative culture and coordinate QA improvement activities with product management, software & product development, test and operational support teams.
Supplier Quality Management
- Lead and support supplier quality improvement activities for the site. This includes alignment and support of the global supplier quality systems and processes.
- Support sourcing initiatives assisting with vendor management and selection.
Qualifications/Skills which this Development role will acquire.
Required
- Degree Qualified in a related subject
- Proven experience in a manufacturing environment preferably in medical devices
- Knowledge of CAPA and understanding of risk application preferably within a medical devices environment
- Problem solving and root cause analysis expertise
- Experience with budgets and cost tracking
- Quality Systems Regulations, knowledge of ISO13485
- Displays Role Model Leadership Skills
- Supervisor/Management experience required, developing people and self
- Effective and open communication and attention to detail
- Must demonstrate strong organizational skills
- Strong team player and leader with the ability to work with other functional leaders and build strong relationships
- Working knowledge of international regulation (with respect to instrumentation).
- Ability to handle critical timelines in a multi-task environment
- Proficient in MS applications (Excel, Word, Outlook)
- Must be available for non-frequent travel if required
Mandatory Requirement – At least one of the bullet points below
- At least 3 years working at a Managerial level in Manufacturing, Quality or related discipline
- At least 3 years working within a ISO 13485 Quality Environment at a Senior Engineering or Supervisory level.
YOUR APPLICATION
Epredia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice.
TO ALL RECRUITMENT AGENCIES
Epredia does not accept unsolicited third party resumes.
Epredia is an Equal Opportunity Employer.
Our Journey. Epredia is on a journey to create an inclusive environment where we celebrate multiple approaches and points of view. Our goal is to attract, develop and retain the best and brightest from all walks of life and backgrounds. Your candidacy will be reviewed regardless of race, religion, gender, sexual orientation, national origin, disability, age or veteran status.
Epredia
www.epredia.com
Portsmouth, United States
John Sweeney
Unknown / Non-Applicable
1001 to 5000 Employees
Company - Public
Biotech & Pharmaceuticals
2019
