Quality - Senior Quality Engineer

Viant Medical•Vega Baja, PR

37d

About The Position

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 Sr Quality Engineer 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 Sr Quality Engineer also communicate with the cross function teams to ensure the quality system compliance, provides training to the team of inspectors. Along with experience with ISO 13485 and 21CRF820, the Sr Quality Engineer also has experience with Combination Devices and/or Pharmaceutical products and applicable regulations (CFR Part 210/211). 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.

Requirements

Minimum of Bachelor's Degree in Technical Field (Engineering or Sciences) is required.
Knowledgeable of processes such as Quality Management System, Documentation and Record Controls, CAPA, Change Management, Quality Audits, Product Quality Nonconformance, Supplier Quality Management, Process and Software Validation is required.
Knowledge of Combination Devices and/or Pharmaceutical products and applicable regulations (CFR Part 210/211).
Knowledge in root cause analysis tools
Proficiency in the use of MS Project.
Intermediate level of knowledge of Minitab statistical software.
Bilingual English/Spanish - Advanced English level (written and spoken), technical writing and capable of leading presentations.
Minimum 5 years of Quality Engineering experience in medical device manufacturing environment and/or pharmaceutical fields is required.
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
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.
Proficiency in at least one manufacturing technical field or any quality subsystem (i.e. process/software validation, CAPA system, statistical techniques, risk management, other.) acquired through either formal training and/or work experience.
Problem Solving: Must be able to formulate and implement mitigations or corrective actions for identified root causes.
Decision making: Capable of making higher risk decisions within specific value streams.

Nice To Haves

Certified as Internal Auditor, Quality Engineer (CQE) or Green Belt in Six Sigma is desired.
Demonstrated use quality tools such as GR&R, pFMEA, Control Chart, Process Capability is desired.

Responsibilities

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 validation strategies against quality system regulation and lead quality engineering teams for the execution of validation plans for assigned quality projects. Review 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.
Provide technical training and support to Quality Engineers of the site as well as to Engineering Assistants and Manufacturing Engineers.
Be acknowledged as a subject matter expert (SME) in at least one quality subsystem (i.e. process/software validation, complaints, NC's, other) required to providing support to the Viant.
Participate and lead communications with the customers including weekly sustaining report out meetings, QBRs, projects meetings, other. Assess compliance with applicable regulations within the manufacturing processes and recommend improvements to ensure that safe and effective products are produced.
Responsible for the preparation of quality metrics required for Management Review, Operations Review or Quality Metrics meetings.