Quality Assurance – Quality Engineer II
San Antonio, TX
The Quality Engineer II is responsible to provide quality support for manufacturing of products as per cGMP requirements and comply with the established quality management system. The Quality Engineer II manages and supervise the processes like incoming quality inspections, product quality controls, investigation of customer complaints, supplier quality audits, CAPAs, and maintain quality system as per ISO13485:2018 and 21CFR 820. The Quality Engineer II also communicate with the cross-function teams to ensure the quality system compliance, provides training to the team of inspectors. Demonstrates Viant values.
This position has the authority to ensure that the nonconforming products are not accepted for manufacturing and released for distribution. The Quality Engineer II supervises the processes that are assigned and delivers performances to meet the goal requirements. This position motivates and provides training for the team of inspectors to ensure timely completion of activities and compliance with the quality system procedures.
Essential Job Functions:
The Quality Engineer II is required to perform the following activities related to at least 2 of the assigned processes such as CAPA, Incoming Quality Inspection, QMS, and Handling of NCR.
- Analyze product nonconformance and customer complaints.
- Maintain quality management systems compliance with the regulations such as 21CFR820 and ISO13485 requirements.
- Trend quality performance metrics and demonstrate continuous improvements.
- Lead CAPAs assigned for effective closure.
- Initiate, review and approve SCARs.
- Conduct assigned Internal Audits, publish audit reports, review and approve audit responses for nonconformance(s)
- Coordinate, plan, perform and report Supplier Audits.
- Assess material risk and develop incoming inspection plans.
- Support preparing and participate in audits including Customer, NB audits and FDA Inspections.
- Review and approve process validation protocols and reports.
- Interact, communicate and timely respond to the customer for Customer issued SCARs, Audit Reports, Complaints, Change Notifications, etc.
- Support for preparing inputs to the management review meeting.
Knowledge and Education:
- Minimum of Bachelor’s Degree in Technical Field (Engineering or Sciences) is required.
- Certified as Internal Auditor, Quality Engineer (CQE) or Green Belt in Six Sigma is desired.
- Knowledgeable of processes such as Quality Management System, Documentation and Record Controls, CAPA, Change Management, Quality Audits, Product Quality Nonconformance, Supplier Quality Management, and Process Validation is required.
- Minimum 3 years of Quality Engineering experience in medical device manufacturing set up is required.
- Demonstrated use quality tools such as GR&R, pFMEA, Control Chart, Process Capability is desired.
- Experience in the following processes is required.
- Standard regulatory requirements such as cGMP, ISO13485:2016 and 21CFR820
- CAPA process
- Participated in internal audits.
- A part of team supporting for 2nd and 3rd party audits and inspections
- Process Validations i.e. IQ, OQ, PQ, & Software Validation
- Statistical Analytical tools such as Process Capability, GR&R, Control Charts
- Risk analysis such as pFMEA
Skills and Competencies:
- Well organized, able to multitask, prioritize and manage multiple deliverables while working in a fast –pace manufacturing environment.
- Exudes values of being customer-centric, accountable, collaborative, and respectful and demonstrates active listening. Self-motivated, with a strong desire to learn and improve self.
- Excellent attention to detail and accuracy. Establishes and maintains high standards for quality and considers excellence a fundamental priority.
- Excellent communication skills, with the ability to create reports and presentations to influence individual or group decision-making, and to provide training to various levels of employees.
- Ability to delegate tasks and projects appropriately according to an individual’s strengths, aptitude and career direction.
- Ability to motivate a team to achieve goals.
- Excellent analytical, technical and troubleshooting skills. Hands-on approach to problem solving.
- Demonstrated understanding and application of modern manufacturing principles and methods to a medical device manufacturing operation.
- Demonstrated proficiency with Microsoft Outlook, Microsoft Project, and Microsoft Office applications.
- Highly self-motivated, focused, self-starter, willing to learn, and take up new responsibility and tasks.
- Ability to work independently and as a part of a team.
Standard office computer and presentation equipment.
- Light physical activity performing non-strenuous day-to-day activities of an administrative nature.
- Minimal lifting (20 lbs.), carrying (10 lbs.), bending, pushing/pulling, crawling, climbing, balancing, and prolonged standing. Manual dexterity sufficient to reach and handle items.
- Requires minimal overnight travel (up to 10%) by land and air.
- Requires the ability to identify and distinguish colors, judge distance and space relationships (i.e., visualize objects of multiple dimensions) and adjust the lens of the eye to bring an object into sharp focus (microscope, etc.).
- Normally works in a well-lighted, air-conditioned, indoor office setting with adequate ventilation.
- Work requires to close visual acuity to perform activities such as: Preparing and analyzing data and figures, transcribing, viewing a computer screen, extensive reading, visual inspection involving small defects, small parts, and/or machine operation, using measurement devices, and assembly or fabrication of parts at distance close to the eyes.