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Senior Quality Engineer
$77k-92k (estimate)
Full Time | Scientific Services 6 Months Ago
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DEKA Research and Development is Hiring a Senior Quality Engineer Near Manchester, NH

DEKA Research & Development, located in Manchester, NH, is seeking a Senior Quality Engineer to provide design quality leadership in a dynamic, fast-paced medical device R&D and manufacturing environment.

How you will make an impact: 

  • Work cooperatively with other team members and in compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016
  • Use critical thinking to determine the best approach
  • Use experience within product development or production and processing of medical devices to provide guidance and assistance in the development of new products
  • Participate and lead in Risk Management activities in accordance with ISO 14971:2019 such as:
    • Development, implementation, and approval of FMEAs
    • Risk analysis of new product designs
  • Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations
  • Assist in the development, implementation, and approval of Device Master Records and Device History Records
  • Lead investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills
  • Coordinate the efforts of individuals and teams performing investigations
  • Ensure the accurate documentation and recording of information to be used in communication with partners and regulatory bodies
  • Prepare detailed work plans such as Master Validation Plans
  • Lead system and process improvements using six sigma tools
  • Provide reliability and statistical analysis
  • Conduct test method validations for formal testing
  • Participate in internal and external audits
  • Interface with partners on quality topics

How you will be successful in this role:

  • Bachelor’s degree in industrial, mechanical or related engineering discipline required
  • Minimum 5 years' experience in any suitable occupation related to quality control of medical devices
  • Experience with medical devices and direct responsibility for Risk Analysis and Design Transfer required
  • Experience with compliance, applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 required
  • Experience developing and leading quality system procedures required
  • Experience supporting regulatory body submissions preferred
  • Experience participating in internal and external audits preferred

About DEKA:

One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Scientific Services

SALARY

$77k-92k (estimate)

POST DATE

09/15/2022

EXPIRATION DATE

07/20/2023

WEBSITE

dekaresearch.com

HEADQUARTERS

MANCHESTER, NH

SIZE

500 - 1,000

FOUNDED

1982

CEO

DEAN KAMEN

REVENUE

$50M - $200M

INDUSTRY

Scientific Services

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About DEKA Research and Development

DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester. DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, design...ers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality. DEKA is filled with people who are driven to be among the best and brightest in their field of work. Its a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers. More
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