ICONMA · 1 day ago
Quality Engineer II
Plymouth, MN
Full-time
Onsite
Mid Level
$29.56/hr - $31.30/hr
3+ years expICONMA is a Medical Device and Healthcare company seeking a Quality Engineer II for their Plymouth, MN location. The role involves identifying and implementing effective process control systems, leading quality assurance processes, and collaborating with engineering teams to ensure product quality and compliance with regulations.
Staffing & Recruiting
Responsibilities
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Design and conduct experiments for process optimization and/or improvement
Appropriately document experiment plans and results, including protocol writing and reports
Lead process control and monitoring of CTQ parameters and specifications
Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
Lead the investigation, resolution and prevention of product and process non-conformances
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
Lead in the completion and maintenance of risk analysis
Work with design engineering in the completion of product verification and validation
Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Qualification
Required
3-5 yrs experience
Degree Required
Benefits
Health Benefits
Referral Program
Company
ICONMA
ICONMA: Your Partner in Global Staffing Solutions and Digital Transformation ICONMA is a globally recognized, Woman-Owned staff augmentation and technology consulting firm.
1001-5000 employees
H1B Sponsorship
ICONMA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (31)
2023 (26)
2022 (39)
2021 (37)
2020 (69)
Funding
Current Stage
Late StageLeadership Team
Claudine George
Founder and CEO of ICONMA, LLC
Company data provided by crunchbase