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Aura Biosciences
Brighton, MA | Full Time
$103k-127k (estimate)
2 Months Ago
Quality Assurance Engineer (Device)
Aura Biosciences Brighton, MA
$103k-127k (estimate)
Full Time 2 Months Ago
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Aura Biosciences is Hiring a Quality Assurance Engineer (Device) Near Brighton, MA

About Aura: At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery. By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.

Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.

Position Summary:

Aura Biosciences is actively recruiting for a Device Quality Assurance Engineer. The Device Quality Assurance Engineer will be responsible for maintaining compliance with global standards, regulation and regulatory bodies to include but not limited to ISO13485 and 21CFR; part 820 The successful candidate will have extensive experience in device acceptance activities, device Quality Systems, development (Design Control, Deviations, CAPAs, etc.) and proactive GMP support of ongoing trials in all phases. 

Responsibilities include but are not limited to:

  • Oversight and management of Development, Design and Design Control Changes of medical devices at Aura
  • Participate in cross-functional teams as the Device Quality Engineering representative supporting all phases of product development (including software as a medical device), design controls and risk assessments.
  • Facilitate and participate in the product risk management process supporting documentation compliant with ISO 14971 such as harm/hazard analysis, FMEAs, risk assessments, etc.
  • Partners with external manufacturers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies and procedures and medical device regulations
  • Partner with Operations, CMC, R&D, Supply Chain, Regulatory, Clinical Operations and other departments to continuously improve products and processes that meet all internal and external requirements and regulations
  • Plan and implement the incoming release activities for all of Aura's incoming devices and components
  • Lead and implement complex projects including Quality Improvement initiatives
  • Sets direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems
  • Lead multiple product Design Control activities for new product development efforts including the review and approval of design history file records. Provide leadership in understanding of the quality regulations to other disciplines
  • Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans 
  • Act as a resource for colleagues in explaining design control and risk management concepts and requirements; may include advising both technical and QA teams on the best approaches to problems
  • Support Process/Design Validation/Verification activities and approach including software validation
  • Author specifications and Justification of Specifications for devices
  • Assist in preparation of global regulatory submissions, documentation, technical files, etc.
  • Support audits of Device vendors and prepare Aura’s Device QMS for audit readiness according to 21 CFR 820 and ISO 13485.

Minimum Requirements:

  • BS in a life science or engineering field required.
  • 5 years of direct GMP device manufacturing experience (combination products preferred)
  • Solid understanding and application of FDA and EUMDR regulations, GMP and all relevant ISO
  • Excellent written and oral communications skills
  • Previous experience writing and approving deviations, CAPAs, change controls
  • A well organized, self-motivated, and independent work style with the ability to initiate and follow through on assignments.
  • Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments
  • Ability to manage changing priorities in a fast-paced environment

Job Summary

JOB TYPE

Full Time

SALARY

$103k-127k (estimate)

POST DATE

01/21/2023

EXPIRATION DATE

02/11/2023

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