Lead medical device validation and remediation activities with a focus on Test Method Validation, Measurement System Analysis, and process qualification. Job Requirements Bachelor's degree in Engineering or a related technical field Senior-level validation engineering experience Medical device industry experience Experience supporting remediation projects Extensive experience with Test Method Validation Experience with Measurement System Analysis Experience developing and executing IQ, OQ, and PQ protocols Experience preparing validation protocols and final reports Experience working within regulated quality systems Experience supporting validation activities in compliance with medical device requirements Preferred Skills Previous successful experience supporting similar medical device validation projects Experience with validation remediation programs Experience with statistical analysis related to test method capability and measurement systems Experience with Gage R&R or comparable measurement system studies Experience supporting CAPA or quality remediation activities Experience with process validation and equipment qualification Experience supporting audits or regulatory remediation efforts Job Responsibilities Lead validation engineering activities for medical device products and manufacturing processes Support remediation projects involving validation gaps or compliance requirements Develop and execute Test Method Validation protocols Perform Measurement System Analysis Conduct Gage R&R and related measurement capability studies as required Write and execute Installation Qualification protocols Write and execute Operational Qualification protocols Write and execute Performance Qualification protocols Analyze validation data and determine acceptance against predefined criteria Prepare validation reports and supporting technical documentation Identify validation deficiencies and implement corrective actions Support process, equipment, and test method qualification activities Maintain validation documentation in accordance with applicable quality system requirements Support engineering and quality teams with validation-related technical assessments

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.