Quality Engineer(Medical Device)
- Employer
- Katalyst Healthcares & Life Sciences
- Location
- Minneapolis, MN
- Closing date
- Oct 24, 2022
View more
- Sector
- Science, Physical Sciences and Engineering
- Organization Type
- Corporate
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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
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