Quality Assurance Technician - Req Exp in Manufacturing or Medical Device Industry

MillenniumSoft Inc; El Paso (TX); On-site; USD 32,000 - 50,000; Full time

Job summary

MillenniumSoft Inc. in El Paso, TX is seeking a Quality Assurance Technician for a 4+ month contract on W2. The role requires day-to-day quality oversight to support manufacturing operations, with in-process inspections and testing to ensure compliance with GMP and GDP.

Responsibilities include leading QA guidance, training personnel, investigations of nonconformances, and maintenance of quality records. On-site only, 1st shift, 40 hours/week.

Qualifications

• High School Diploma or GED required.
• Associate degree or technical degree in a scientific/technical field preferred.
• 3+ years of Quality Assurance experience preferred.
• Knowledge of cGMP, GDP and regulatory requirements.
• Strong analytical, problem-solving and troubleshooting skills.
• Proficiency in Microsoft Office applications, particularly Excel.

Responsibilities

• Provide day-to-day quality oversight and technical leadership to support manufacturing operations.
• Perform in-process inspections, audits, sampling, testing and quality system activities to ensure products meet specifications and regulatory requirements.
• Support GMP, GDP and Quality System compliance through training, deviation management and NCR handling.
• Lead/assist investigations and root cause analyses for quality issues and nonconformances.
• Maintain quality records and assist in internal and external audits.

Skills

Quality oversight

Excel

Troubleshooting

Analytical thinking

Leadership

Education

High School Diploma/GED

Associate Degree preferred

Tools

Microsoft Office

Excel

Job description

Job Category : Quality

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT

Job Title - Ld Tech, Quality Assurance

Position : Quality Assurance Technician

Location : El Paso, TX

Duration : 4+ Months

Total Hours/week : 40.00

1st Shift

Client : Medical Devices Company

Job Category : Quality

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT

Job Title - Ld Tech, Quality Assurance

Temp to Perm role Pay rate $23-$36 On site

Job Description -

• Responsible for providing day-to-day quality oversight and technical leadership to support manufacturing operations.
• Performs quality inspections, process audits, sampling, testing, and quality system activities to ensure products meet established specifications, regulatory requirements, and quality standards.
• This role supports manufacturing operations by providing quality guidance, training, investigation support, nonconformance management, and oversight of activities to ensure compliance with GMP, GDP, and Quality System requirements.

Job Responsibilities:(Primary Duties, Roles, and/or Authorities)

Quality Oversight & In-Process Activities

• Perform in-process inspections, audits, sampling, and testing activities in accordance with approved procedures, specifications, and sampling plans.
• Monitor manufacturing processes through routine quality audits and observations to verify compliance with approved procedures and quality requirements.
• Conduct quality inspections using approved methods, equipment, and techniques.
• Perform raw material inspections to verify compliance with established specifications.
• Verify that finished products meet applicable specifications prior to release or disposition.
• Ensure proper handling, identification, and traceability of materials, samples, and quality records throughout the manufacturing process.

Leadership & Training

• Provide day-to-day guidance and technical support to Quality Assurance Technicians and designated manufacturing personnel.
• Assist with onboarding and training of QA Technicians and production associates on quality requirements, inspection methods, sampling practices, GMP, GDP, and applicable procedures.
• Support qualification and ongoing competency assessment of personnel performing quality-related activities.
• Serve as a quality resource for manufacturing operations by promoting compliance and quality awareness.

Deviation Management, Investigations & Escalation

• Identify, document, and elevate nonconformances (NCR(QNs)), deviations, and abnormal conditions through established quality systems.
• Support containment, investigation, and disposition activities associated with nonconforming materials and products.
• Collaborate with Manufacturing, Engineering, and other cross-functional teams to investigate quality issues and support root cause analysis.
• Assist in implementation and follow-up of corrective and preventive actions intended to prevent recurrence of identified issues.
• Provide timely communication and escalation of quality concerns to Quality leadership and impacted functions.

Quality Systems & Continuous Improvement

• Support development, revision, implementation, and maintenance of quality procedures, work instructions, and forms.
• Support compliance with Quality Management System requirements through audits, inspections, and routine monitoring activities.
• Maintain accurate, complete, and contemporaneous quality records in accordance with Good Documentation Practices (GDP).
• Support internal audits, external audits, regulatory inspections, and audit readiness activities.
• Perform statistical analysis, trending, and evaluation of quality data to identify opportunities for improvement and communicate findings to management.
• Prepare and maintain quality metrics, reports, and summaries as required

Compliance & Documentation

• Ensure compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), company policies, and applicable regulatory requirements.
• Execute activities in accordance with approved SOPs, Work Instructions, specifications, and quality standards.
• Maintain required training qualifications and certifications.
• Support data integrity, documentation accuracy, and record retention requirements.

Safety & Compliance

• Demonstrate compliance with site safety requirements and actively support safety initiatives.
• Maintain required safety training and certifications.
• Adhere to all company policies and procedures.
• Perform other duties as assigned to support business needs.
• Responsible for providing day-to-day quality oversight and technical leadership to support manufacturing operations.
• This role supports manufacturing operations by providing quality guidance, training, investigation support, nonconformance management, and oversight of activities to ensure compliance with GMP, GDP, and Quality System requirements.

Education And Experience

• High School Diploma/GED required.
• Associate Degree or Technical Degree in a scientific, technical, or related discipline preferred.
• 3+ years of Quality Assurance experience preferred.

Knowledge And Skills

• Working knowledge of cGMP, GDP, Quality Systems, and regulatory requirements.
• Experience conducting inspections, audits, and quality-related activities in a manufacturing environment.
• Strong analytical, problem-solving, and troubleshooting skills.
• Proficiency in Microsoft Office applications, particularly Excel.
• Ability to interpret specifications, procedures, and technical documentation.
• Strong communication, organizational, and leadership skills.
• Ability to identify, evaluate, and elevate quality issues appropriately.