Quality Technician (Medical Device Industry/ Catheters/ Failure Analysis) Position Available In Middlesex, Massachusetts

Quality Technician (Medical Device Industry/ Catheters/ Failure Analysis) (part of Adecco) 3.8 3.8 out of 5 stars Billerica, MA 01821 100% onsite for a top Medical Device company in Billerica, MA. Complaint processing from field devices. Disposable and capital equipment devices. New facility. Testing and troubleshooting of medical devices. Failure analysis. Receive device, unbox (biohazard), sterilize devices, perform failure analysis, document. Enter complaint record information. Catheter experience is a bonus. Destructive testing to source root cause. 1st shift

• Failure Analysis
• Experience with Returned Product complaint analysis – (returns are considered biohazard and need to be disinfected) inspection and troubleshooting
• Able to manage inventories of devices inside the lab – include shipping/handling to other labs
• Able to follow testing work instructions and document findings
• HS Diploma & 2+ years of exp Failure Analysis Technician III role.

This includes, but is not limited to the following: Execute product Inspection and test plans on bio-hazard product. Identify failures, potential causes, and capture the supporting objective evidence. Generate product analysis reports. Provide support with the development of procedures, processes, tools, and techniques for performing product analysis. Coordinate and link information from multiple sources/systems to analyze problems thoroughly. Nice to

Have:

Medical device industry experience.

Familiarity with these regulations:

FDA 21 CFR

Part 820, EU 217/745 (EU MDR).

Familiarity with these standards:

ISO 13485, ISO 14971, IEC 60601.

Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS. Strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team.

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled 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 To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #

GRPC Job Types:

Full-time, Contract Pay:

$23.00 – $27.00 per hour Expected hours: 40 per week

Schedule:

Monday to Friday People with a criminal record are encouraged to apply

Work Location:

In person