Quality Assurance Engineer II

Description:

Quality Assurance Engineer: II

Position Summary

• Responsible for ensuring compliance and following all regulations and quality systems within our international distribution centers. Perform time and temperature analysis for shipments within the US and LATAM distribution network. Responsible for creating quality events, obtaining dispositions, and product release for products at US distribution centers.

Primary Duties

• Evaluate shipments using TTOR and MKT principles.
• Initiating quality events, liaising with manufacturing sites for dispositions and distribution centers for product release.
• Executes assigned quality projects, with guidance from technical quality expert (depending on level of experience), using engineering principles, business standards, practices, procedures, and project requirements.
• Assures proper documentation of technical data generated for the assigned projects and/or tasks consistent with applicable quality directives and procedures.
• Communicate the quality status of materials to internal customers, management, and external suppliers.
• Develop and implement departmental operational procedures to ensure regulatory compliance (FDA, GMP, ISO, OSHA, etc.).
• Make recommendations for improving quality & productivity performance.
• Contribute continuous product and process improvements in areas related to department.
• Leads the following activities contributing to QMS compliance: CAPA (including analysis of data and trends in complaints, nonconforming materials and root cause analysis), change control, supplier quality, internal audits, quality training, etc.
• Works with other departments to ensure operational and quality goals are understood and met.
• Participates and communicates status, business issues, and significant developments in projects.
• Develop and review procedures (both internal and external).

Supplemental Data

• Information that will enhance the understanding of the nature of the job (e.g., number of people directly supervised, total staff supervised, sales volume impacted, operating budget, extent of travel required, etc.)
• Makes decisions based primarily on defined guidelines and procedures, but responsible for scheduling of work to meet product demands and deadlines.

Qualifications

Training and Education

• Minimum education and/or training requirements for this position (i.e., high school diploma, college degree, and/or certification).
• Bachelors degree in scientific or technical field, including Pharmaceutical or Medical Device experience, or related field

Experience

Minimum time and type experience required for this position.

• Requires a 4-year degree in scientific or technical field.
• Requires a minimum of 0 to 4 years work experience in scientific or technical field.
• Requires effective written and oral communication skills.
• Competence in the selection and use of Quality Engineering tools, techniques, and processes.
• Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
• Must be able to demonstrate flexibility in responding to unexpected demands. Must also be able to work in team environment, building effective working relationships.
• Knowledge of GMP, ISO, and FDA compliance.

Soft skills:

• Competence in the selection and use of Quality Engineering tools, techniques, and processes.
• Ability to work independently and in team environment
• Good communication skills

Preferred Qualifications :

• Technical writing skills preferred
• Knowledge of client reagents and instruments preferred

Preferred Past Experience:

• Science, Pharmaceutical, Manufacturing, Quality

Notes: Onsite First Shift, Monday-Friday, no overtime, no company holidays, no weekends VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status