Job Description

A contract manufacturer and injection molding client is looking to hire a Senior Quality Engineer in Forest Lake, Minnesota. This quality professional would sit 100% onsite and ideally comes from a plastic injection molding background.

Skills Needed:

• Bachelor’s degree in engineering or related field, or equivalent experience in a contract manufacturing environment, preferably in regulated industries.
• 8 years of experience in quality engineering
• Experience with med devices, plastic injection molding and/or contract manufacturing

Duties of Position:

• Work cooperatively with all employees in a team environment
• Serve as the quality representative on cross-functional new product development teams.
• Review all documents and specifications referenced on the drawing or purchase orders, identify concerns and communicate to the cross-functional new product development team. Drive drawing and specification changes needed to effectively transfer projects to production.
• Proactively lead and anticipate the needs of the customer and/or project and develop plans to mitigate risks encountered during the project.
• Respond in a timely and professional manner to internal and external customer requests that pertain to quality.
• Understand and follow regulatory requirements for FDA, ISO and Government standards.
• Develop and optimize validation protocols and execute reports to meet regulatory, customer and internal production requirements.
• Develop inspection plans, fixtures and methods to achieve quality requirements and standards, document quality issues identified during development and to ensure best practices are implemented.
• Work closely with the metrology team to schedule and drive product first article inspections, capability studies, gage R&Rs, etc. Review data to ensure accuracy for submission to customers.
• Investigate and determine root cause of product quality issues and defects for new products and implements solutions to resolve issues; assist other personnel, as required, with the Corrective Action process
• Establish and execute priorities for multiple programs of varying complexity to achieve customer expectations based on new product development schedules established by the program management team.
• Drive continual improvement in regard to procedures, processes, work flow, compliance to standards, and to ensure product quality.
• Provide project knowledge and insight to Sustaining Engineers and support production issues as needed.
• Responsible for performing internal audits, as required, based on internal audit schedule.
• Mentor and provide guidance, in regard to quality and project related issues, to less experienced team members to drive personal and professional growth of the team, timely and appropriate resolution of issues.
• Proactively identify gaps, and potential solutions to resolve them, in existing equipment, resources and technology to ensure the quality team is well-positioned to address ever-changing market and customer needs.

Salary range for this role: $95,000-$140,000K

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