Sr. Quality Engineer, Circle Pines

Sr. Quality Engineer

New Yesterday

Title: Senior Quality Engineer
Salary: $90k-$120k
Location: Columbus, MN area (Northern Twin Cities Suburbs)
Requirements:

Bachelor's degree in Engineering or related field preferred; equivalent experience in a contract manufacturing environment-especially within regulated industries-will be considered.
Minimum of 8 years of quality experience, with at least 2 years focused on plastic injection molding.
Must possess valid identification and be legally authorized to work in the United States without the need for current or future sponsorship.

Essential Functions:

Collaborate effectively with all employees in a team-oriented environment.
Serve as the quality representative on cross-functional teams for new product development.
Review drawings and purchase order documentation, identify potential concerns, and communicate findings to the product development team; drive necessary changes to ensure seamless production transfer.
Proactively anticipate customer/project needs and develop risk mitigation strategies.
Provide timely, professional responses to internal and external quality-related inquiries.
Ensure adherence to regulatory requirements including FDA, ISO, and government standards.
Develop, optimize, and execute validation protocols to meet regulatory, customer, and internal production requirements.
Create inspection plans, develop appropriate fixtures and methods, and document issues to ensure best practices are implemented.
Collaborate with the metrology team to schedule and execute first article inspections, capability studies, and gage R&Rs; review and validate data accuracy for customer submission.
Lead root cause investigations and corrective actions for new product quality issues; support ongoing improvements to the corrective action process.
Manage and prioritize multiple programs of varying complexity to meet development schedules and customer expectations.
Continuously improve procedures, workflows, compliance, and product quality.
Provide support to Sustaining Engineers and production teams as needed.
Conduct internal audits as required per the audit schedule.
Mentor junior team members by providing guidance on quality and project-related topics to support team growth and issue resolution.
Identify equipment, resource, or technology gaps and propose solutions to enhance the quality team's ability to meet evolving market and customer demands.
Perform other duties as assigned by supervisor.

Due to ITAR regulations, this role is only open to U.S. Citizens, lawful permanent residents (green card holders) or foreign nationals granted refugee or asylee status. Individuals with temporary visas (e.g. E, F-1, H-1, H-2, L, B, J, TN or OPT) are not eligible for hire in this role.

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Location:: Circle Pines

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