Function:
The QARA department is critical to maintaining quality compliance and product safety at Phagenesis, and the Quality Engineer role is vital to the department's success. The position reports to the Senior Quality Engineer and involves both Quality Assurance activities e.g., supplier management and development of the QMS system; and Quality Control activities e.g., product inspection and release. The position also involves working in or supporting of other areas of the business on an as needs basis.
Responsibilities:
Lead supplier management activities such as: SCAR's, KPl's, supplier assessments, supplier audits, supplier agreements, supplier requalification, supplier monitoring.
Lead root cause investigations and implement corrective actions for NCMR's and CAPA's.
Lead investigation of complaints to determine the root cause and applicable corrective actions.
Inspect incoming and final product.
Review & approval of label specifications.
Inspect and release of labels.
Review & approval of Device History Records (DHR) and other production documentation
Review & approval of equipment records, including calibration and preventive maintenance
Execute product release.
Contribute to continuous improvement of the QMS including the implementation of new and revised QMS processes/documentation.
Prepare data and participate in QMS Management Reviews and QA Metrics meetings.
Provide support in the preparation and hosting of internal and external audits.
Manage the change control process.
Essential Experience:
A familiarity with operating to ISO13485 and 21 CFR Part 820 compliant processes & procedures
QA and preferably QC experience in a medical device company
Degree qualified or quality qualification
Product Training Level:
Inspector / Investigator Level
Desirable Experience:
At least 4 years experience as a quality professional in a medical device company
A track record in supplier evaluation and monitoring
Experience of product inspection and release
Familiarity with management of complaints and non-conformances
ISO13485 lead auditor trained
Key Competencies:
High attention to detail
Collaboration & teamwork
Excellent verbal and written communication skills
Good analytical, critical thinking and problem solving skills
Ability to work independently and within cross-functional teams