inSync Staffing
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Base pay range
$60.00/hr - $80.00/hr Direct message the job poster from inSync Staffing Duration:
6-month contract Overview
Responsible for process validation to ensure FDA/ISO compliance and audit readiness for medical device manufacturing. Qualifications
Bachelor’s or Master’s in Engineering. 7+ years in medical device industry and product development. Knowledge of FDA QSR and ISO 13485 quality systems. Strong documentation, communication, and problem-solving skills. Detail-oriented, adaptable, and comfortable in a cleanroom environment. Experience in startup environments preferred. Key Responsibilities
Maintain up-to-date knowledge of FDA, ISO, GHTF guidance. Own all process validation documentation: Master Plan, Reports, IQ/OQ/PQ/PPQ, PFMEA, Monitoring Plans. Perform DOE and physical testing using equipment like Instron, Mark 10, Micro-Vu. Validate manufacturing processes (adhesive bonding, UV cure, pouch sealing, 3D printing, braiding, laminating, thermoforming, laser cutting/welding, etc.). Conduct Attribute and Variable Test Method Validation. Apply statistical methods for sample size determination and documentation. Manage projects with Gantt charts, task lists, and meetings. Solve problems using A3 and Six Sigma DMAIC methods. Support related validations: Facility, Packaging, Sterilization, eQMS, Netsuite/ERP/CRM. Benefits
Health Insurance Health Savings Account Vision Insurance Flexible Spending Accounts Life Insurance Retirement Plan All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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$60.00/hr - $80.00/hr Direct message the job poster from inSync Staffing Duration:
6-month contract Overview
Responsible for process validation to ensure FDA/ISO compliance and audit readiness for medical device manufacturing. Qualifications
Bachelor’s or Master’s in Engineering. 7+ years in medical device industry and product development. Knowledge of FDA QSR and ISO 13485 quality systems. Strong documentation, communication, and problem-solving skills. Detail-oriented, adaptable, and comfortable in a cleanroom environment. Experience in startup environments preferred. Key Responsibilities
Maintain up-to-date knowledge of FDA, ISO, GHTF guidance. Own all process validation documentation: Master Plan, Reports, IQ/OQ/PQ/PPQ, PFMEA, Monitoring Plans. Perform DOE and physical testing using equipment like Instron, Mark 10, Micro-Vu. Validate manufacturing processes (adhesive bonding, UV cure, pouch sealing, 3D printing, braiding, laminating, thermoforming, laser cutting/welding, etc.). Conduct Attribute and Variable Test Method Validation. Apply statistical methods for sample size determination and documentation. Manage projects with Gantt charts, task lists, and meetings. Solve problems using A3 and Six Sigma DMAIC methods. Support related validations: Facility, Packaging, Sterilization, eQMS, Netsuite/ERP/CRM. Benefits
Health Insurance Health Savings Account Vision Insurance Flexible Spending Accounts Life Insurance Retirement Plan All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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