Quality Assurance Engineer II

Job Description

Job Description

Description :

Job purpose The Quality Engineer II will be responsible for developing, revising, and maintaining Quality processes, procedures, and metrics to support all functional areas at Vivex Biologics, Inc. This individual will be responsible for providing Quality guidance in process improvement and technology transfer efforts. The Quality Engineer II will initiate and lead non-conformances and deviations investigations, corrective and preventive action development and implementation, and ensure their timely completion. The role will also be responsible for reviewing and approving process validation and equipment qualification (IQ, OQ, PQ) protocols and reports. Duties and responsibilities Ensure company is in compliance with all internal policies and procedures and external federal, state, and governing body regulations and standards.Responsible for initiating and leading technical investigations, risk assessments (including FMEA), root cause analysis, and corrective and preventive actions related to non-conformances, deviations, and customer complaints.Work cross-functionally to provide quality and regulatory guidance to all functional areas in the organization.Participate in quality planning activities to evaluate existing and develop new measurement systems to evaluate and improve departmental output. Identify process improvement opportunities using Lean principles and lead the development and implementation of process improvements activities.Perform pre-validation assessments and review and approval of process validation and equipment qualification (IQ, OQ, PQ) protocols and reports.Other duties as assigned.

Requirements : Qualifications

• A minimum of a bachelor’s degree in engineering or a related technical discipline is required (e.g. Biology, Chemistry, etc.).
• A minimum of 5 years of related Engineering or Quality experience is required.
• Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry preferred.
• Experience with Non-Conformances, Deviations, Complaints and Corrective and Preventive Actions (CAPAs) required.
• Experience with Process Validations and Equipment Qualifications.
• Expert knowledge in the interpretation and application of FDA, AATB, and ISO standards and guidelines.
• American Society for Quality (ASQ) certification preferred.
• Certified Tissue Bank Specialist (CTBS) certification preferred.
• Must demonstrate effective oral, written, communication and presentation skills.

Working conditions

Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled cleanroom manufacturing area where the engineer would be exposed to tissue processing.

Physical requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and / or move objects weighing up to 30 pounds.

Direct reports

No direct reports.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time.

Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and / or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.

Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.