Biohazard Lab Technician II - Neurovascular - Irvine, CA (Onsite)
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
The technician role in the biohazard laboratory is responsible for the analysis of returned products, investigation of alleged product issues and assessment of likely causes in accordance with quality system regulations.Responsibilities may include the following and other duties may be assigned:
Perform decontamination and testing of returned products to determine in-specification/out-of-specification conditions, product failures and likely causes. Interpret data and document analysis findings in the global complaint handling system.
Escalate new and unique product failures to ensure timely resolution of potential product safety and quality issues. Partner with upstream/downstream customers as required for further investigation of failures and communicate findings as necessary.
Ensure maintenance of complaint evaluation standards in partnership with internal partners (R&D, RPE, CQXM).
Maintain biohazard lab in accordance with environmental health and safety requirements. Ensure timely calibration of devices and troubleshooting of equipment as necessary.
Improve and streamline work processes to drive efficiencies.
Ensure understanding of all quality system regulations applicable to the role. Follow all work/quality procedures to ensure quality system compliance.
Maintain awareness of new products, government regulations and requirements.
Performs a variety of duties in the electronic, mechanical, electromechanical, and/or optical areas.
Constructs, troubleshoots, calibrates, adjusts, tests, diagnoses, and maintains equipment, components, devices, or systems.
Works from schematics, engineering drawings and written or verbal instructions.
Operates related equipment; conducts tests and reports data in prescribed format.
Performs calibration and alignment checks; adjusts, modifications, and replacements as directed; prepares prescribed compounds and solutions.
Required Knowledge and Experience:
Requires minimum of 2 years of relevant experience.
Requires high school diploma or equivalent (United States), vocational or technical education or certification (all other countries).
Nice to Have
Returned product analysis and complaint investigation experience
Knowledge of the complaint handling process
Experience working in a bio-hazard laboratory and compliance with environmental health and safety requirements
Comprehensive and extensive knowledge of all Neurovascular products and clinical uses
Experience with root cause analysis, and/or DMAIC methodologies for driving process improvements
Knowledge of 21CFR, Section 820, Quality System Regulation and ISO 13485, Quality Systems, Quality Management Systems, 45CFR Parts 160 and 164 Patient Privacy Rule- HIPAA Regulations
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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