Senior Validation Engineer responsible for validation activities, remediation support, test method validation, measurement system analysis, and execution of

IQ/OQ/PQ

protocols within a medical device environment. Job Requirements Bachelor's degree in Engineering or a related technical discipline. Senior-level validation engineering experience. Medical device industry experience. Experience supporting remediation projects. Experience with Test Method Validation (TMV). Experience with Measurement System Analysis (MSA). Experience writing and executing Installation Qualification (IQ) protocols. Experience writing and executing Operational Qualification (OQ) protocols. Experience writing and executing Performance Qualification (PQ) protocols. Experience developing and maintaining validation documentation. Preferred Skills Experience supporting medical device validation remediation programs. Experience with process validation and equipment qualification. Experience performing gauge or measurement system studies. Experience reviewing and resolving validation gaps or nonconformances. Experience working in regulated manufacturing environments. Knowledge of medical device quality system and validation requirements. Job Responsibilities Develop and execute validation plans and protocols. Write and execute IQ, OQ, and PQ documentation. Perform Test Method Validation activities. Conduct Measurement System Analysis and related studies. Support validation remediation projects. Review existing validation documentation and identify gaps. Develop corrective validation documentation and testing strategies. Analyze validation and test data. Document validation results and prepare final reports. Support process, equipment, and test method qualification activities. Maintain validation records in accordance with applicable medical device quality requirements. Support resolution of validation-related findings, deviations, and nonconformances.

Pay:

70-80/hr Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details:

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for

Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.