Job Title: Quality System Auditor
Job ID: QAUD09
Position Location: Spartanburg, SC / Anacortes, WI.
Job Type: Contract
Project Duration – 6 months (possible extension to a year)
AnumTech is seeking an experience Quality System Auditor (Contractor) with focuses on software quality. We are willing to train the right candidate to be fully qualified. The individual will be responsible for delivering AnumTech’s audit services to assigned clients in accordance with applicable industry standards, industry best practices and regulatory requirements to assure timely, cost effective service delivery that assures satisfaction of our customer needs.
The ideal candidate will need to have experience working in the capacity of a Quality System Auditor / Quality Manager / Project Manager Quality Assurance / Quality Improvement Specialist / Quality Engineer or related roles.
- Perform Quality System Audits based on International Standards, Industry best practices and regulations ((ISO/CMMI/FDA Etc).
- Evaluate current process, procedures and documents pertaining to development, testing, and release of software systems against industry standards and best practices.
- Continuously look for quality improvement in SDLC and related processes and communicate the recommendations.
- Develop audit plans and audit agenda.
- Prepare Audit report detailing audit findings, gaps, improvement opportunities, quality and compliance risk.
- Work individually or as part of a team under the direction of a lead auditor or supervisor to examine, question, evaluate and report the findings.
- Communicate action items and escalate issues to the lead auditor or supervisor
- Prepare audit reports and trending of related information.
- Assist in writing and reviewing QA standard operating procedures
- Train other auditors and create job aids and other related material as required
- Must demonstrate proficiency with audit procedures and adhere to good documentation practices and QA departmental policies and procedures.
- Maintain audit files to ensure all documentation is current and complete.
- Assumes additional duties and responsibilities as assigned.
Education, Skills and Experience:
- A Bachelor’s degree required; preferably in
Engineering, Biology, Math, Chemistry or Computer Science.
- 5+ years SDLC experience, at least 3 of them as Quality System Auditor/Quality Manager / Project Manager Quality Assurance / Quality Engineer or related roles.
- Working knowledge of Quality System Auditing, Industry Standards and best practices (ISO 9001/CMMI etc).
- Working knowledge of Software Development Life Cycle and related processes.
- Knowledge of Agile Scrum methodology and related tools is a plus.
- Strong knowledge of Software QA methodologies, tools, and processes.
- Knowledge of FDA 21 CFR Part 11 is a plus.
- Experience performing Risk Management, CAPA, Root cause Analysis and Quality Improvement activities.
- Advanced computer skills including: Word, Excel, PowerPoint and management of spreadsheets and generating reports.
- Apply effective time management, critical thinking, problem solving and collaborative approaches to improving audit program.
- Ability to analyze situations thoroughly, identify potential problems, find and recommend effective solutions.
- Ability to work independently with minimum supervision and in a collaborative team environment
- Excellent oral and written communication skills
- Ability to successfully keep track of several projects at one time, adhere to tight deadlines and maintain a positive, helpful attitude.
- Adaptable and willing to shift to other duties to meet changing work-loads.
- Auditor certification from ASQ/ISO or equivalent is a plus
- PC proficient, ability to use different database applications, strong MS office skills, especially Excel and Power Point.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex,
sexual orientation, gender identity, national origin, disability or protected veteran status.
Physical Requirements/Work Environment:
This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and
digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.
PLEASE NOTE: This is a contract role; not a full time/employee hire.
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