Quality Technician/Medical Device Position Available In Middlesex, Massachusetts

Quality Technician/Medical Device CO Billerica, MA 01821 Quality Technician III Billerica, MA 01821 12

Months PR:

$ 26/hr on W2

HM’s Top Needs:

1. Experience with Returned Product complaint analysis – (returns are considered biohazard and need to be disinfected) inspection and troubleshooting 2. Able to manage inventories of devices inside the lab – include shipping/handling to other labs 3. Able to follow testing work instructions and document findings

Education Required:

High School diploma.

Years’ Experience Required:

Minimum of 4+ years of relevant work experience and may require vocational or technical education or certification in addition to prior work experience. In general, the following responsibilities apply for the 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. Must Have – Minimum Requirements

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

High School diploma. Minimum of 4+ years of relevant work experience and may require vocational or technical education or certification in addition to prior work experience. 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 Type:

Contract Pay:

$25.48 – $26.45 per hour

Schedule:

8 hour shift Monday to

Friday Education:

High school or equivalent (Preferred)

Experience:

FDA 21 CFR

Part 820: 5 years (Required)

EU 217/745

5 years (Required) ISO 13485 and

ISO 14971

5 years (Required)

IEC 6060

5 years (Preferred)

Work Location:

In person