Flex-Staff Inc. · 15 hours ago
Quality Engineer (Medical Device Industry Experience required), Temporary, Remote
United States
Contract
Remote
Mid Level
$40/hr - $40/hr
3+ years expFlexStaff is seeking a Quality Engineer with experience in Medical Device manufacturing to work with one of their clients, a leading global distributor of healthcare products and services. The role involves developing and implementing systems to ensure products meet customer expectations and regulatory requirements.
Human ResourcesService IndustrySmall and Medium BusinessesStaffing Agency
Responsibilities
Continuous Improvement: Identify and recommend enhancements in product design and manufacturing processes. Provide quality engineering support for risk management, design changes, and CAPA investigations
Quality System Expertise: Author, review, and approve Quality System documentation, including NCMR and Engineering Change Control
Supplier Quality Improvement: Drive supplier quality through engineering analysis and root cause investigations. Collaborate with suppliers to reduce defects and improve yield
Trend Analysis: Conduct periodic product and process trend analyses to ensure quality, patient safety, and regulatory compliance. Implement corrective actions and problem-solving methodologies to reduce defects
Product Development Guidance: Offer quality engineering insights for product and process improvements, validating design inputs related to usability, reliability, safety, and manufacturability
Quality Control Planning: Assure product quality in line with best practices, including material control and process validation, based on risk management outcomes
Validation and Testing: Author validation and inspection assessments to ensure product release readiness. Select tests and sampling sizes based on criticality
Regulatory Compliance: Stay updated on relevant quality standards (e.g., Medical Device Directive, US FDA) and adapt quality processes to meet changing requirements
Computer System Validation: Perform computer system validation and ensure adherence to regulatory standards
Qualification
Required
Three (3) or more years of experience in product engineering, manufacturing engineering and/or quality engineering within the Medical Device Industry
A Bachelor's Degree in engineering
Strong working knowledge of medical device regulations including 21CFR820, MDD, MDR and other global regulatory requirements and quality system standards including ISO14971, IEC 60601 and other relevant standards
Company
Flex-Staff Inc.
Flex-Staff is a second generation, family-owned staffing services company headquartered in Appleton, Wisconsin.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Steve Kamrowski
CEO
Company data provided by crunchbase