- 189627 - Quality Engineer II
- Up to $29.99 DOE
- 1 year
- Chipton-Ross is seeking a Quality Engineer II for an opening in Austin, TX.
As a QA Engineer, you will help to ensure the Austin site meets all the requirements for ISO-9001, ISO-13485, 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA), Quality Systems Regulation (QSR), and USDA regulations. You can help make an impact by providing site QA support including audit readiness, data collection, and reporting on Management metrics. You’ll also handle & manage complaint cases, investigate, review and approve problem records, CAPAs, and process change orders.
Duties will include complaint handling, will work with the cross-functional department on complaint cases for investigations, root cause analysis, and corrections/corrective actions to ensure proper documentation and closure, provide trending and escalations as appropriate. Analyze and trend all types of data (CAPA, problem records, complaints, on market surveillance) to identify deficient areas and initiate quality improvement projects. Participate in internal audits per ISO 13485 and 9001 requirements and ensure site audit readiness. Participate in third-party audits, external customers, and Agency inspections as needed. Support internal Quality activities concerning any identified nonconformities. Write and review CAPAs to ensure timely resolution of quality problems. Support creation of training plans and update training database to maintain compliance. Participate in departmental projects and improvement initiatives through the site’s PPI Program and partner with other groups to continuously improve. Prepare clearly written business communications, including audit reports, gap assessments, validations, etc. Write, review, analyze and revise written relevant Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Site, Regulatory Requirements as directed. Generate and fulfill customer request for COAs, COCs, COOs. Perform other duties to support the quality and regulatory department as assigned.
Providing Quality oversight for issues of significant scope and complexity across multiple functional groups in order to ensure adherence to ISO standards. Creating problem reports for nonconforming raw material. Ensuring discrepancies are thoroughly identified, defined, and properly assessed. Interacting with interdepartmental contacts on change and discrepancy assessment, resolution, and quality approval. Providing timely information to Operation. Update and meet metrics. Identifying opportunities for continuous improvement of the Quality Systems and participate in implementation. Maintain calibrated tools and equipment. Be able to communicate technical issues and inspection results orally and in writing. Ability to work independently and as part of the QA Team. Sense of urgency with completion of projects and tasks. Serves as a backup for other Quality positions as needed.
Accredited High School Diploma/GED
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.