Location:Brackley Northamptonshire UK
AboutUs: Our Client is a pioneering medical devicemanufacturer dedicated to enhancing patient care through innovativesolutions. Committed to upholding the highest standards of qualityand compliance. Our Client is looking for a diligent anddetailoriented Quality Associate with ISO 9001 experience to joinour team.
BulletPoints:
* Minimum of 3years of experience in quality assurance or a related role withinthe medical device industry.
* Knowledge of ISO9001 standards and quality managementsystems.
* Certification in Quality Management(e.g. ASQ CQE).
* Experience with other qualitystandards and regulations (e.g. ISO13485)
JobDescription:
PositionOverview: The Quality Associate will play a crucialrole in supporting the Quality Management System (QMS) to ensurecompliance with ISO 9001 standards. This position involvesconducting quality assurance activities assisting with audits andmaintaining documentation to support our medical devicemanufacturing operations.
KeyResponsibilities:
* Supportthe implementation and maintenance of the Quality Management System(QMS) in compliance with ISO 9001 standards.
* Assist with internal and external auditsincluding preparation documentation and followup on findings.
* Maintain and manage quality recordsdocumentation and reports to ensure accuracy and compliance.
* Conduct quality assurance activities such asinspections testing and calibration.
* Participate in the investigation andresolution of quality issues nonconformances and customercomplaints.
* Monitor quality performancemetrics and assist in identifying areas for improvement.
* Collaborate with crossfunctional teamsincluding production engineering and R&D to ensure qualitystandards are upheld.
* Provide support intraining staff on quality processes and procedures.
* Contribute to continuous improvementinitiatives to enhance product quality and optimize manufacturingprocesses.
* Stay updated on industry trendsregulatory changes and best practices in quality management.
Qualifications:
* Bachelorsdegree
* Strong organisational and documentationskills.
* Excellent communication andinterpersonal abilities.
* Analytical andproblemsolving skills.
* Proficiency in qualitymanagement software andtools.
Benefits:
* Competitivesalary
* Retirement savings plan with companymatch.
* Opportunities for professionaldevelopment and career advancement.
* Collaborative and supportive workenvironment.