Quality Engineer

• Work independently to initiate, investigate and support quality Events, Complaints and CAPA's and SCARS.
• Coordinate and maintain customer complaint & CAPA management system, validations for all departments, along with the Calibration Program and the Environmental Monitoring Program.
• Write and implement methods and procedures for supporting the quality management system.
• Review and approve quality assurance procedures and reports.
• Coordinate the implementation of process controls to support manufacturing operations.
• Review and approve methods and procedures for supporting the quality management system.
• Support the implementation of client's Business Solutions (ABS) initiatives.
• Participate in the investigation, resolution, and prevention of product and process non-conformances.
• Provide support for validations.
• Facilitate audits (both internal and supplier) and support compliance with applicable Regulatory Quality System standards.
• Participate in supporting quality decisions.
• Support, coordinate and maintain service provider qualification and monitoring.
• Conduct root cause analysis investigation and perform risk assessment and evaluations to identify appropriate corrective action.
• Conduct quality assurance tests and performs statistical analysis to assess the level of control and manage product quality risks.
• Employ Quality Engineering tools and techniques to develop, align and optimize systems and processes.
• Participate and support Tier Daily Management
• Write reports and facilitate its use for supporting the quality management system.
• Support service provider qualification and monitoring.
• Ensures the cleanliness of work areas.
• Performs other duties as assigned by the Manager.
• Follows applicable safety procedures.

Qualifications:

• Bachelor's degree in a natural/life science field with knowledge and experience in one of the following areas: medical device, biotech, or pharmaceutical industry is preferred.
• 3-5 years of experience in quality engineering, quality assurance, or similar role.
• 3 - 5 years of proven experience conducting and supporting audits.
• Collaboration Tool: Must be proficient in MS Office (Word, Excel, Access)
• Certified Quality Engineer (CQE)/Certified Quality Auditor (CQA) certification preferred.

Preferred:

• Demonstrated experience or knowledge in conducting root cause analysis as it relates to investigations and CAPAs.
• GMP knowledge required.
• Experience using an ERP system.
• Experience with using a QMS.
• Advanced analytical and problem-solving skills required.
• Advanced project management skills preferred.
• Knowledge and experience utilising Microsoft Outlook, Word, Excel, and Access, or equivalent software packages.
• Support and participate in Customer Complaints, SCARS, CAPA and Root Cause Analysis
• Knowledge of lean methodologies
• Experience with creating, developing, and executing protocols, method transfer and training programs preferred.
• Experience with internal and external audits
• Training experience preferred.
• A technical writing skill set is required.
• Able to collaborate with all levels of employees is required.
• Knowledge of inspection tools and techniques.
• Good interpersonal skills
• Good attention to detail
• Good mathematics skills.
• Ability to read, understand, and follow procedures.
• Working knowledge of ISO 9001:2015 Standard.
• Self-motivated and able to work independently and with a team.
• Good written and oral communication skills are required.
• Must be detail-oriented, with strong organisational skills, ability to multitask, prioritise workload and work independently to meet commitments with minimal direction is required.

If this job is a match for your background, we would be honoured to receive your application!

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