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Mindlance · 9 hours ago

Quality Engineer II

Plymouth, MN

Full-time

Onsite

Mid Level

3+ years exp

Mindlance is a company seeking a Quality Engineer II to enhance their product development and manufacturing processes. The role involves implementing process control systems, leading quality assurance initiatives, and collaborating with engineering teams to ensure compliance with quality standards.

Human Resources

H1B Sponsor Likely

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

Process control systemsSix SigmaLean ManufacturingQuality Management SystemsProblem-solving methodologiesRisk analysisProtocol writingCollaboration

Required

3-5 yrs experience

Degree Required