About the Position
We are seeking a skilled Quality Assurance Professional to oversee the implementation of quality systems and regulatory compliance in our medical device manufacturing processes.
This role is critical in ensuring the highest standards of quality, which is essential for patient safety and satisfaction. The ideal candidate will have 2-3 years of experience in medical device manufacturing, preferably within orthopaedics, and possess a strong technical foundation in quality systems and engineering.
Key Responsibilities
* Oversight and maintenance of the Quality Management System (QMS) ensuring compliance with ISO 13485, FDA, MDR, and other applicable regulations.
* Leadership and execution of quality engineering activities including risk assessments, root cause analysis, CAPA, change control, and supplier quality management.
* Support of product development and manufacturing by reviewing technical documentation and design transfer activities.
* Performance and coordination of internal and external audits, management of audit responses and follow-up corrective actions.
* Collaboration with cross-functional teams including manufacturing, engineering, and regulatory affairs to resolve quality issues and implement process improvements.
* Management of non-conformance reports (NCRs) and timely investigation, documentation, and resolution.
* Provision of training and guidance on quality processes, regulatory requirements, and best practices to staff at various levels.
Required Skills and Qualifications
* Bachelor's degree in Engineering, Quality, or related field preferred.
* 2-3 years' experience in a quality engineering or quality assurance role within the medical device manufacturing industry.
* Strong knowledge and practical application of ISO 13485, FDA QSR, MDR requirements.
* Experience with QMS documentation, CAPA, audits, risk management, and change control.
* Proficiency in problem-solving, root cause analysis, and quality data analysis tools.
* Ability to work collaboratively across departments in a regulated environment.
Benefits
* Certification in Quality Engineering, Six Sigma, or related quality management disciplines is highly desirable.
* Experience with statistical process control (SPC), process validation, and supplier quality management would be an asset.
* Familiarity with orthopaedic implant manufacturing processes and cleanroom environments would also be beneficial.
* Proficiency in quality software such as Minitab, Q-Pulse, or equivalent tools would be advantageous.