What are the responsibilities and job description for the Quality Engineer position at TALENT Software Services?
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 Devens, MA.
Primary Responsibilities/Accountabilities:
- Use Quality Engineering principles, tools, and techniques to develop and optimize systems and processes so that they are aligned with company strategy and regulatory requirements.
- Provide support for customer, regulatory, and internal audits.
- Use root cause analysis and risk assessment tools and techniques to perform investigations and determine appropriate corrective action.
- Lead, coordinate, and maintain validations for all departments.
- Lead, coordinate, and maintain Calibration Program.
- Lead, coordinate, and maintain the Environmental Monitoring Program. Conduct audits (both internal and supplier) and monitor compliance with ISO and FDA Quality System Regulation standards.
- Collect, review, and interpret data for trend report, metrics, quality system review, and complaints.
- Update the approved supplier index as required. Review and approve quality assurance procedures and reports.
- Maintain SOPs and Quality Management System as directed by the QA Manager.
- Performs other duties as assigned.
Qualifications:
- Bachelor's degree in a natural/life science discipline with knowledge and experience in one of the following areas: Chemistry, Biology, Microbiology, or cell culture; or an equivalent combination of education, certification, and experience.
- CQE/CQA certification preferred.
- Minimum 3-5 years relevant experience.
- Excellent written and oral communication skills are required.
- Able to interface effectively with all levels of employees.
- Must be proficient in MS Office (Word, Excel, Access).
- Experience in deviation and complaint investigations, including root cause analysis tools and technical writing required.
- Must be detail-oriented, with strong organizational skills, ability to multitask, prioritise workload, and work independently to meet commitments with minimal supervision.
- Experience conducting and supporting audits is required.
Salary : $35 - $40
