neteffects
Pay Range:
$60–$80/hr, paid weekly
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.).
Support supplier validation for processes like laser welding, injection molding, luer bonding.
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 (Employee Contribution) Health Insurance
Health Savings Account
Dental Insurance
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–$80/hr, paid weekly
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.).
Support supplier validation for processes like laser welding, injection molding, luer bonding.
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 (Employee Contribution) Health Insurance
Health Savings Account
Dental Insurance
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.
#J-18808-Ljbffr