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Senior Remote Quality Assurance Engineer

Date Posted: 3/24/2023

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Job Description

Senior Engineer, Quality Assurance Engineering

Position: Senior Quality Engineer
Location: Remote (USA home office)
Duration: 6 months with possible extension
Pay Terms: Up to $70.00/hr. by W2


Support Quality Engineering activities in new product development to ensure the highest level of product and process quality.

Essential duties & responsibilities:

  • Develop quality assurance documentation to support new product development process and regulatory submissions.
  • Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices.
  • Engage in the design, development, manufacturing, and risk management activities for new product development projects.
  • Engage in design reviews by identifying risks associated with the product used and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
  • Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
  • Complete final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
  • Promote efficient testing practices. Support Advanced Operations in the development of manufacturing processes for new products.
  • Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
  • Develop, review, and approve inspection plans, routers, and product drawings for new products.
  • Support product design transfers to internal and/or external manufacturing facilities.
  • Evaluate predicate products for relevant quality issues that may impact new product development projects.
  • Analyze and define critical quality attributes for product and process through risk analysis techniques.
  • Participate in collection of initial market feedback on new products and address early concerns.
  • Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
  • Lead investigation and health risk assessment for post-market events.

Education & special trainings:
  • Minimum of 2 years work experience in Medical Device or other regulated industry preferred.
  • Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.
  • Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
  • Demonstrated ability to read and interpret CAD drawings. Thorough knowledge and understanding of US and International Medical Device Regulations.
  • Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
  • Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.
  • Demonstrated ability to advocate for product excellence and quality.
  • Demonstrated ability to effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing. Strong interpersonal skills, written, oral communication and negotiations skills.
  • Strong in critical thinking and "outside the box" thinking.
  • Highly developed problem solving skills. Strong analytical skills.
  • Demonstrated ability to successfully manage and complete projects in a matrix organization.
  • Demonstrated ability to work independe
    To apply please email your resume to

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Job Snapshot

  • Employee Type:Full-Time
  • Location:Home-Based, NJ
  • Job Type:Engineering
  • Experience:Not Specified
  • Education:Not Specified
  • Date Posted:3/24/2023
  • Contact: Heather Walsh (949) 620-0292
  • Pay Range: $0.00 - $70.00 Hourly
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Job Reference: JO-2303-197675