Job Description
Are you an experienced Quality Engineer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Quality Engineer to work at their company in Morrisville, NC.
Primary Responsibilities/Accountabilities:
- 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 perform 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 a 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.
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