Midnight Oil · 1 day ago
Quality Engineer Medical Device
Shakopee,MN,US
Full-time
Onsite
New Grad, Entry Level
0+ years expMidnight Oil is seeking a Quality Engineer to drive preventative quality measures for their medical device customers. The role involves designing inspection mechanisms, addressing customer quality complaints, and ensuring compliance with regulatory standards.
Art & CreativeAdvertisingMarketingCreative Agency
Responsibilities
Design inspection and testing mechanisms to conduct quality assurance tests and perform statistical analysis to assess the cost of and determine the responsibility for product or materials that do not meet required standards and specifications
Drive preventative quality measures that support the needs of medical device customers
Assist in other quality assurance functions, such as addressing customer quality complaints, ensuring compliance with certifications, and facilitating the completion of internal quality defects, helping to move the plant towards a total quality manufacturing facility
Work closely with customers, as well as all levels of the company
Work directly with medical device customers to lead the timely completion of supplier corrective action requests (SCARs), corrective and preventive actions (CAPAs)
Collaborate with internal functions on corrective actions that include training, process improvements, Standard Operating Procedures (SOP) updates, quality audits, and validation efforts
Prepare and present reports and compliance documentation to medical customers
Maintain and review documentation for regulatory submissions and inspections related to product quality; read customers’ specs, artworks, and drawings
Ensure products meet all regulatory requirements, including FDA, ISO, and other relevant quality standards
Assist in maintaining and developing Quality Management System (QMS) to requirements of ISO 9001:2015, Quality Manual, and current company objectives
Provide guidance and training on medical quality standards and best practices to internal teams
Perform root cause analysis events and ensure the completion of action items, which include training, CAPA activities, quality audits, validation efforts, and standard work revisions
Responsible for completing documentation in a timely manner and in accordance with business standards
Participate in companywide continuous improvement projects
Facilitate customer quality visits and support audits
Develop and deliver training programs to build skills and reinforce quality standards
Perform dimensional and functional inspections and tests on equipment including calipers, pin gauges, and pressure gauges
Qualification
Required
Master's degree or foreign equivalent degree in Engineering, Chemistry, or closely related field
At least 6 months of experience in a quality assurance specialist/inspector position, or closely related occupation
At least 6 months of experience with resolving supplier complaints, such as supplier corrective action requests (SCARs), corrective and preventive actions (CAPAs), and root cause analysis
At least 6 months of experience performing quality assurance and validation tasks, such as gathering and interpreting complex data
At least 6 months of experience drafting documentation, records, and reports ensuring compliance with business procedures and quality system regulations and ISO standards
At least 6 months of experience maintaining and developing quality management systems (QMS)
At least 6 months of experience assessing products and materials during and after manufacturing to ensure they meet required quality standards
At least 6 months of experience performing dimensional and functional inspections and tests on equipment including calipers, pin gauges, and pressure gauges
Company
Midnight Oil
Midnight Oil is a marketing agency that provides go-to-market, brand strategy, print production, structural design, and audience insight.
201-500 employees
Funding
Current Stage
Growth StageRecent News
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