Description
Quality Compliance OfficerMy medical device client is looking for a Quality Systems and Reporting Officer to join their company based in Oxfordshire.
Key Activities:
- Undertaking Quality Audits (Internal & Supplier)
- Maintain and report on quality metrics
- Providing QA support and approval of non-conformances, deviations, corrective / preventive actions (CAPA)
- Responsible for logging, monitoring and closing audit actions, internal and external
- Assisting the business in closing CAPA actions
- Assisting in the improvement and development of QMSs
- Provides training to site staff on quality system elements and processes
- Perform review of batch records to support product release
- Reviewing and updating Quality System procedures as required
- Provide Training & Support to the users in the Quality IT Solutions
- Ensure the high profile Quality system is adhered to and that ISO & UKAS standard requirements are met and maintained
Formal Education & Certification
- University degree is desirable and ideally in scientific field
- Lead Auditor in ISO9001, ISO13485 is desirable
Knowledge & Experience
- 3 years direct work experience in a Quality Assurance role
- 3 years direct work experience with maintaining ISO9001, ISO13485 certifications & accreditations is desirable
- Experience in developing and deploying quality assurance best practices, policies, procedures, and processes.
- Must have a full clean driving license
Personal Attributes
- Experience at working both independently and in a team-oriented, collaborative environment is essential.
- Can conform to shifting priorities, demands, and timelines through analytical and problem-solving capabilities.
- Persuasive, encouraging, and motivating.
- Advanced interpersonal, written, and oral communication skills.
- Adept at conducting research into quality related issues.
- Must be able to learn, understand, and apply new technologies.
- Ability to effectively prioritize and execute tasks in a high-pressure environment is crucial.
- Tenacious.
If you are interested please apply with an up to date copy of your cv or call Bethany on