Quality Engineer(Medical Device)

Katalyst Healthcares & Life Sciences
Minneapolis, MN
Closing date
Oct 9, 2022

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Job Description Responsibilities:
  • Ensure Design Control in accordance with 21 CFR 820 and ISO 13485 is implemented at appropriate phase gates in Medical Device development
  • Ensure appropriate Design History Records are maintained in accordance with 21 CFR 820 and ISO 13485 for Medical Device development
  • Assist in medical device design review meetings to provide engineering and quality requirement subject matter expertise
  • Identify and drive quality requirements and improvement opportunities in future & existing medical device and consumer products and manufacturing processes
  • Generate Quality Documents such as protocol, report, risk documents, etc for medical devices and consumer products
  • Lead Risk Management and FMEA activities for compliance in accordance with ISO 14971 for Medical Devices and assist with review process FMEAs from OEM partners
  • Support FMEA activities for consumer products
  • Collaborate with technical failure analysis to support root cause analysis and issue resolution for Corrective and Preventive Actions (CAPAs)
  • Manage quality escalation issues as directed by the Sr. Director of Quality Engineering and Regulatory Affairs
  • Conduct periodic reviews of Field/Factory Quality Data and drive compliance and improvement projects
  • Attend new product development builds, participate in OEM audits and other activities as required
  • Conducts and coordinates external supplier audits as assigned to ensure QMS compliance
  • Daily quality support for issues arising in incoming inspection, production and product quality
  • In conjunction with corporate Quality System, reviews customer complaints to determine corrective action in regard to suppliers
  • Initiates and drives continuous process & yield improvement projects throughout Owlet's supplier base
  • Leads projects related to supplier complaint investigation, CAPAs, cost reduction and quality system excellence
  • Works closely with suppliers to ensure the right parts meeting specifications are delivered on time
  • Bachelor's in Engineering Field
  • Experience in medical device design is preferred
  • Experience with supplier quality within a consumer product, consumer appliances, or other electro technical product category a plus
  • Detail oriented and well organized
  • Ability to work with cross-functional teams
  • Ability to act independently to solve complex problems
  • Experience writing procedures, and training others
  • Wide range of technical experience/skills
  • Use independent research to formulate action plans.
  • Understanding of database management and report generation a major plus
: 22-00277 : Minneapolis, MN:

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