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Validation Quality Technician
Posted: 06/04/2026
Industry: Pharma/ Med Device Engineering
Job Number: 26-77826
Pay Rate: 28-30 USD/Hour
Job Description
Job Description...
The Quality Technician is responsible for executing Test Method Validations, Process Validations, and other engineering studies in accordance with written protocols and procedures to maintain the validated state of Insulet’s product manufacturing and quality processes. The Quality Technician collaborates with Quality Engineering to ensure new and existing products conform to the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971 throughout the design transfer to manufacturing process as well as product lifecycle. He/she is responsible for maintaining strong Quality Records in compliance with Good Documentation Practices (GDP). He/she will serve as a Quality representative on wide scale remediation efforts to ensure compliance to both internal and external requirements in areas including process risk management, test method validation, and process validation.
Responsibilities:
Education and Experience:
Skills and Competencies:
EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.
The Quality Technician is responsible for executing Test Method Validations, Process Validations, and other engineering studies in accordance with written protocols and procedures to maintain the validated state of Insulet’s product manufacturing and quality processes. The Quality Technician collaborates with Quality Engineering to ensure new and existing products conform to the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971 throughout the design transfer to manufacturing process as well as product lifecycle. He/she is responsible for maintaining strong Quality Records in compliance with Good Documentation Practices (GDP). He/she will serve as a Quality representative on wide scale remediation efforts to ensure compliance to both internal and external requirements in areas including process risk management, test method validation, and process validation.
Responsibilities:
- Follow validation and verification protocols to execute engineering studies, process validation, test method validation (Gage R&R and Attribute Agreement Analysis), and process verification studies.
- Enter and maintain data in compliance with internal and external Quality Records requirements, following Good Documentation Practices (GDP).
- Excellent attention to detail, good organization, and capable of working independently with minimal instruction from production supervisor.
- Able to work in small groups and cross functional teams to troubleshoot issues, identify and implement collective corrective actions.
- Performs other duties as required
Education and Experience:
- High School Diploma or GED
- Experience in Quality in an FDA regulated industry.
- Experience with performing test method validation and process validation of medical device products.
- Experience with word processing, spreadsheet, database programs.
Skills and Competencies:
- Self-starter capable of dealing with a variety of tasks in a fast paced, multi-tasking environment.
- Must be proficient in English language to be able to read documentation, communicate, and write.
- Ideal candidate will have keen eye for quality, is dependable, and will work collaboratively within a team, and possess a positive attitude.
- Previous experience working in a clean room environment.
- Manufacturing and/or inspection experience in a regulated industry is a plus.
- Knowledge of raw materials, measurement instruments, production processes, quality control, and other techniques for the manufacture / inspection of medical devices.
- Recognizes problems and understands root cause analysis techniques/concepts.
- Experience with ETO sterilization methods preferred.
- Ability to generate and maintain accurate records.
- Ability to follow up with task owners to close out open items.
EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.
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Staffing Leader of the Year Anju Abel
CEO, LanceSoft
LanceSoft is proud to announce that its Chief Executive Officer, Anju Abel, has been honored with the prestigious "Staffing Leader of the Year" award at the 2025 TIARA Staffing Awards US. The award recognizes her visionary leadership and significant contributions to improving staffing processes, employee engagement, and workforce outcomes.
Anju Abel's leadership has been instrumental in transforming LanceSoft's global staffing operations. Her focus on innovation, employee satisfaction, and client-centric delivery has led to higher retention rates, a motivated workforce, and enhanced operational efficiency.
"This award is a testament to the incredible team at LanceSoft and our unwavering commitment to redefining staffing solutions," said Anju Abel. "I'm honored to receive this recognition and proud of the impact we continue to make in the lives of our clients and talent worldwide."
The judging panel highlighted Anju's ability to consistently deliver outstanding client success stories, exceed expectations, and foster professional development within her team. Her active community involvement and dedication to advancing the staffing industry were also key factors in her selection.
TIARA Awards are known for celebrating excellence, innovation, and achievement in the talent acquisition sector, and this accolade places Anju among the top leaders reshaping the future of workforce solutions.