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Cytrellis Biosystems
Woburn, MA | Full Time
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Fusion Optix
Woburn, MA | Full Time
$54k-69k (estimate)
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Quality Assurance Technician
Full Time | Medical Technology 8 Months Ago
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Cytrellis Biosystems is Hiring a Quality Assurance Technician Near Woburn, MA

Summary:

As part of our transformation initiative from an Engineering based company to a Commercial enterprise with our first FDA cleared product this position is a critical member of the Quality Team. The QA Technician remains independent working in Q&R but works closely with the Operations team by providing inspection of incoming materials and final product release of finished goods. The QA Technician will further support the Operations team by ensuring Quality on the Floor through effective audit and oversight activities.

Essential Duties and Responsibilities:

  • Responsible for ensuring that final products meet specification(s)
  • Responsible for ensuring incoming materials meet specification per AQL or other sampling plans
  • Responsible for recording accurate inspection information when inspecting product/materials.
  • Some overtime hours may be required to meet customer expectations.
  • Needs to be aware of safety requirements of the company.
  • Contributes to team effort by being an important part of the Quality Team.
  • Helps to contribute to the overall success of the company.
  • Perform Quality on the Floor ‘audits’ such as calibration reviews, Preventive Maintenance, ESD reviews, material bin reviews, expiration date compliance, etc.
  • Review Device History Records
  • Part of the Material Review Board (MRB) as an action owner to perform any nonconforming material segregations, documentations, etc.
  • Assist with product quality investigations over time through the repair depot process
  • Other duties as assigned.

Education and/or Experience:

  • Must have a high school diploma or equivalent
  • Two-year technical degree preferred
  • Minimum of 3 years work experience with any combination of schooling above, or two-year technical degree with applicable internship from manufacturing/inspection environment demonstrating competence in stated job duties
  • Must have a basic understanding of inspection tools and how to use them.
  • Experience reviewing Medical Device, Device History Records (DHR) strongly preferred
  • Prior Experience with Medical Device/FDA regulated industry strongly preferred
  • Manufacturing experience preferred
  • Prior inspection experience required
  • Experience in understanding drawings/blueprints required.
  • Experience in troubleshooting, investigation techniques required
  • Attention to detail Critical
  • Working knowledge of Good Documentation Practices
  • Cytrellis QMS is in English, all documentation is in English
  • Work cooperatively in a team environment

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Cytrellis values diversity and we are committed to creating an inclusive environment for team members from all backgrounds. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin or veteran status or any other protected class.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Medical Technology

POST DATE

07/09/2022

EXPIRATION DATE

10/07/2022

WEBSITE

cytrellis.com

HEADQUARTERS

Woburn, MA

SIZE

25 - 50

INDUSTRY

Medical Technology

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Cytrellis Biosystems
Full Time
$103k-125k (estimate)
1 Week Ago

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The following is the career advancement route for Quality Assurance Technician positions, which can be used as a reference in future career path planning. As a Quality Assurance Technician, it can be promoted into senior positions as a Quality Assurance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Technician. You can explore the career advancement for a Quality Assurance Technician below and select your interested title to get hiring information.