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Design Assurance Engineer

Redbock

Elkton, MD

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JOB DETAILS
SALARY
$60–$84 Per Hour
JOB TYPE
Contractor
SKILLS
Quality Engineering, Hardware Quality Assurance, Quality Assurance Methodology, Corrective and Preventative Action (CAPA) Systems, Quality Management
QUALIFICATIONS
  • 4+ years of experience product development / R&D teams and excellent engineering and manufacturing knowledge related to new products
  • 6 years of medical device quality assurance, including strong design assurance background
  • Solid understanding of 21 CFR 820, ISO 13485, ISO14791 and other related regulatory and quality standards
  • Proven experience with Minitab, FMEA risk assessment, and Statistical Process Control (SPC) for process improvement, test method validation, and design history files
  • Experience reviewing design documentation (drawings, specifications, DHFs, test data sheets, etc.
  • Excellent written, verbal, and interpersonal communication skills
  • Relevant BS degree
  • Medical Device industry auditing experience is a plus, as are Quality and SIX Sigma certifications
RESPONSIBILITIES
  • Provide Quality Engineering and Design Assurance Support related to material specifications, inspections, drawings, manufacturing SOPs, and related testing, and help drive quality system development, implementation and compliance
  • Oversee metrology, inspection, measurement systems and non-conformance activities, and provide leadership supporting QA plans, risk management, CAPA systems, and root cause analysis
  • Review tech transfer plans and reports for design transfer compliance
  • Team meetings and communications and production of relevant, compliant documentation.
  • Other related duties, as required
LOCATION
Elkton, MD
POSTED
13 days ago

Quality Engineer needed to support product development Design Assurance efforts for a medical device innovator.

About the Company

R

Redbock

Redbock is a specialized life sciences consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies. We provide expert solutions to resource-challenged companies, and positively impact the lives of the consultants helping them.

Over the years, our consultants have brought solutions to some of the largest, high-profile companies in the industry. We specialize in quality assurance, regulatory and compliance, engineering, clinical operations, and biometrics.

Redbock is now a part of NES Fircroft - an award winning workforce solutions company, that provides candidates across the Life Sciences, Energy, Construction/Infrastructure, Manufacturing, Chemicals, Mining and IT sectors. 

 

HEADQUARTERS
San Diego, California, US
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
2010