Overview
Medical Device Regulatory, Quality, and Test Lead Jobs in Indianapolis, IN at EchoTech.ai
The Quality Support Lead (Quality Control Inspector/Safety/OSHA) coordinates and conducts internal quality audits and performs Quality Assurance support activities in area of responsibility to ensure performance meets contractual requirements.
Conduct field audits of contractual services for conformance to Performance Work Statement
Responsible for all aspects of QC activities at assigned location.
Act as quality point of contact for customer inspectors, site management, and field operations managers
Maintain currency of QC procedures and recommend revision of internal specifications when needed.
Assist in implementation and maintenance of inspection system components and methods.
Provide response to customer concerns and findings; track corrective actions taken in response to internal and customer audit findings.
Implement and maintain software and procedures consistent as updates and changes occur.
Provide support for quality training preparation and presentation.
Provide support for quality analysis and data presentations made to management and customers.
Assist site managers, supervisors, and functional leads with internal and customer corrective action reporting.
Manage non-conformities identified during QA/QC inspections.
Perform other qualified duties as assigned.
Minimum Requirements
Knowledge of inspection methods and processes
Ability to understand relationship between QA/QC activities and contract performance.
Ability to work with personnel at all levels.
Ability to effectively and efficiently implement the Program QC Plan.
Required at least five years of experience in quality assurance to include quality management system certification or compliance to industry quality standards.
Required at least one year experience planning and leading quality assurance audits.
Required experience with establishing key performance metrics.
Required at least two years of supervisory experience.
Required at least two years of aviation or aircraft maintenance experience.
Additional experience/education may be required by assignment or contract.
Drivers License
High School Diploma or GED Equivalent
Clearance Requirements:
Must be able to obtain and maintain a (SECRET Clearance) US Government Clearance. US Citizenship is required to obtain a secret clearance. Must be able to obtain and maintain facility credentials/authorization. US Citizenship is required for facility credentials/authorization at this work location.
Physical/Preferred Requirements
Typical office environment with no unusual hazards
Occasional lifting to 20 pounds
Constant sitting while sing the computer terminal.
Constant use of sight abilities while reviewing documents.
Constant use of speech/hearing abilities for communication.
Constant mental alertness
Must possess planning/organization skills.
Must be able to work under deadlines.
Amentum is proud to be an Equal Opportunity Employer. Our hiring practices provide equal opportunity for employment without regard to race, religion, color, sex, gender, national origin, age, United States military veteran’s status, ancestry, sexual orientation, gender identity, marital status, family structure, medical condition including genetic characteristics or information, veteran status, or mental or physical disability so long as the essential functions of the job can be performed with or without reasonable accommodation, or any other protected category under federal, state, or local law. Learn more about your rights under Federal EEO laws and supplemental language at EEO including Disability/Protected Veterans and Labor Laws Posters.
Title: Medical Device Regulatory, Quality, and Test Lead
Company: EchoTech.ai
Location: Indianapolis, IN
