Quality Systems Engineer
Job ID: JOB-13344
Reporting to the Quality Systems Leader, duties will include implementing & maintaining the Company’s Quality Management System in accordance with applicable standards and regulations.
- Provide support for the key elements of the Quality Management System (QMS), which includes, but not limited to: CAPAs, Internal Audit Program, Complaints, Change Control, QMS deviations, QMS documentation, policies, and GMP / Behavioural Based Quality.
- Manage and provide guidance on Data Strategies for Change Control process
- Actively supports site CAPA system, mentors associates on CAPA process, co-ordinates preparation of data for CAPA review Meetings etc.
- Actively supports internal audit program for the site and identify areas of potential noncompliance or improvements.
- Be a primary contact to other departments such as engineering and operational functions to provide assistance and support on quality system requirements
- Responsible for ensuring adherence to internal and external regulatory requirements
- Be a key member of the onsite audit team during external audits, e.g. from Regulatory Authorities and Global Corporate Quality.
- Assist and facilitate Complaint investigations ensuring effective root cause analysis and assigning of appropriate CAPAs. Ensure appropriate
- Risk Management activities are completed at all stages of CAPAs, CAPA Initiation (CID), Complaints and Quality Notifications
- Assist and co-ordinate the preparation of data for Management review Meetings for all products manufactured on site.
- Assist and co-ordinate implementation of global standards and corporate procedures into the site Quality Systems.
- To actively support the development/implementation and continuous improvement of the Quality Management Systems.
- To be cross trained in multiple quality systems.
- Develop and write SOP & Controlled Documents.
- Continuously review and improve quality documentation including, SOPs, Policies, Guidelines, Specifications, Investigations, Complaints, GMP records and other Quality Management System Documentation as required.
- Participate in other projects as directed by the Quality Manager.
- Compilation of monthly metrics for Plant management and Unit QA Co-ordinate / generate quality metrics / reports for weekly meetings
- Where relevant, take ownership of Corrective and Preventive Actions, and track progress through Trackwise or similar e-CAPA systems.
- Support Quality Engineering / Continuous Improvement activities as required. Ensure adherence to all BD regulatory requirements. Promotion of Quality Awareness, Culture, cGMP and BD Values within the Plant.
- Training of associates on Quality procedures and initiatives Support third part Audits and Inspections
- Degree Qualified in Engineering, Science or Quality related discipline.
- 3+ Years relevant work experience in a regulated medical device or pharmaceutical environment.
- Proven working experience with FDA QSR and ISO 13485. Strong understanding of change and project management
- Proven track record in problem solving, root cause analysis and supporting quality notification / CAPA resolution.
- Ideally Qualified ‘lead auditor’ experience.
- Six Sigma or similar statistical background would be advantageous
- Experienced in technical writing and review
- Experience in CAPA system management
- Proven ability of working in a cross-functional team environment.
- Excellent interpersonal and communication skills and high level of computer literacy.
- Good understanding of cGxPs
- Significant experience working within an established Quality System
For further information on this role in please contact Nela Dobrusova on 0861283369 or email firstname.lastname@example.org.
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