Job description

Experience in working in Consumable Medical devices, Combination Products and knowledge in medical device quality process.

Should have worked in medical new product development projects & sustenance projects.

Experience with System Engineering processes, such as requirements traceability and using tools such as, DOORS.

DXL scripting is added advantage.

Experience in change control process.

Should have worked in ISO 13485 / 21CFR820 (design control processes)/ ISO 14971 compliant environment.

Should understand Risk Management activities (Risk Management Plan, Hazard Analysis, User Error Risk analysis, FMEA & Risk Management Report) for Consumables (IV Administration sets, syringes, etc.) per ISO 14971 standard.

Lead and manage risk management activities for post market surveillance analysis.

Understand and create linkages between risk management files and complaint code specifications.

Provides written reports and engineering documentation by following cGMP practice.

Ability to review and analyze engineering reports / documentation.

Experience in verification, validation or other rigorous testing and lab processes design to document conformity as common in a regulated environment.(Preferred, Not Mandatory).

Exposure to Human Factor Engineering (Preferred, Not Mandatory).

Excellent written and verbal communication is a must.

Job Types: Full-time, Contract

Salary: $35.00 - $50.00 per hour

Benefits:

• Health insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift

Work setting:

• In-person
• Manufacturing facility
• Warehouse

Ability to commute/relocate:

• Norton, MA 02766: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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