Overview
Quality Tech Jobs in East Flat Rock, NC at WestRock
About Aquabiliti:
We transform water into medical-grade solutions (AQUALutions) that promote the highest levels of safety and purity.
Aquabiliti’s fully customized systems empower life sciences, CGT, biotechnology, pharmaceutical and medical device manufacturers to optimize efficiency, reduce costs, and mitigate risks in producing cutting-edge, life-sustaining applications.
Our commitment to flexibility ensures seamless integration of Water for Injection (USP-EP) grade filled customized Single-Use Systems into the unique processes of life sciences manufacturers. With a vertically integrated approach, our core competencies span design and development, custom SUS production, assembly, aqueous solution filling, and packaging engineering.
We use a low-temperature sterilization process to create products such as the AquaStat SFP (Sterile Fluid & Path) and AquaStat SFR (Sterile Field Ready) Saline Flush Syringes.
GENERAL STATEMENT OF DUTIES:
Responsible for Quality Engineering tasks that support effective and efficient operations that comply to 21 CFR Part 820 and ISO 13485. This is a broad assignment that may include document creation, document review (including DHRs for product release, statistical calculations, projects, calibrations, validations, verifications, and environmental testing. Includes as assigned investigating product or process non-conformance, investigating complaints, leading Corrective or Preventive Action teams, and performing Internal and Supplier Audits. Provides training to individuals and small or large groups as assigned.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Produce, track and trend quality metrics, generates and submits timely reports to update Management Review and other meetings as assigned.
Perform or execute oversight of systems, reports and programs that affect quality or regulatory compliance as selected by QA/RA Management. (e.g. environmental testing, water testing)
Ensure document compliance with QSR (SOPs, records retention, calibration).
Verify device Device History Records comply with the DMR as part of product release. Advise/review on issues related to lot releases.
Ensure product and process specifications have been defined and meet regulatory requirements, utilizing Risk Management and Mitigation tools.
Evaluate manufacturing changes for compliance with appropriate change control systems/process and determine regulatory filing strategy utilizing Risk Management and Mitigation tools
Assess documentation to support product and process changes and update or approve as necessary.
Author and execute protocols and create final reports for validations, verifications, and studies.
Support the Product Development Process and ensure defendable practices and scientific analyses are employed.
Provide quality representation on projects.
Develop and initiate standard procedures and methods for inspection, testing, and evaluation.
Assist or lead the development or correction of procedures, work instructions, and forms as assigned.
Training of operators, technicians, and other employees as assigned to assure all employees have proper training and awareness of their responsibilities within a global medical device company
Evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment; and facilities as assigned.
Develop and implement methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility. Maintain the Material Review Area to ensure that all products are distributed in a timely manner.
Direct workers engaged in measuring and testing product and tabulating data concerning materials, product, or process quality and reliability.
Maintenance and the distribution of QA/QC assigned measuring equipment as well as calibration requirements.
Suggest and implement changes in working conditions and use of equipment to increase safety and efficiency of shop, department, or work crew.
Lead and implement assigned corrective and preventive actions to ensure compliance of the quality management system with applicable quality and regulatory standards. Perform VoE as assigned.
Accompany inspection teams or auditors
Function as an Internal Quality System Auditor for internal or supplier audits as assigned.
Other duties as assigned.
SUPERVISORY RESPONSIBILITIES:
No Direct Reports
BEHAVIORS AND TEAM SKILLS:
Able to educate and influence others
Able to work in a team environment
Follow written and verbal direction
Make sense of complex data and communicate effectively
Organize multiple tasks and drive to completion
EDUCATION REQUIRED:
Bachelor’s Degree in Engineering, Life Sciences or related field.
PHYSICAL DEMANDS:
Must possess sight/hearing senses, or use prosthetics that will enable these senses to function adequately so that the requirements of this position can be fully met. Physical activity includes walking, standing, bending, squatting, reaching above shoulders and lifting up-to 40lbs. Must be able to drive an automobile for short and long distances. This position must spend long hours using a computer, which can cause eye strain. This position must manage multiple/many requests and time-sensitive situations at one time, resulting in stress.
WORK ENVIRONMENT:
Performs activities in a lighted and ventilated area. May be subject to cleanroom work or changes in temperature and dust on occasion. Normally works in an office environment, with no abnormal hazards or risks. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Job Type: Full-time
Pay: $75,000.00 – $80,000.00 per year
Benefits:
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
Day shift
Monday to Friday
Experience:
Quality assurance: 3 years (Preferred)
Ability to Commute:
Nashville, TN 37211 (Required)
Ability to Relocate:
Nashville, TN 37211: Relocate before starting work (Required)
Work Location: In person
Title: Quality Tech
Company: WestRock
Location: East Flat Rock, NC
