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Lead Quality Engineer
4 weeks ago
Join a dynamic team at a contract manufacturer specializing in injection molding. We are seeking an experienced Lead Quality Engineer to work onsite in Forest Lake, Minnesota. This is an exciting opportunity for a quality professional with a strong background in plastic injection molding and a passion for delivering high-quality medical devices.
Essential Skills:
- Bachelor's degree in engineering or a related field, or equivalent experience in a contract manufacturing setting, with a preference for regulated industries.
- Minimum of 8 years of hands-on experience in quality engineering.
- Experience in the medical device sector, along with expertise in plastic injection molding and contract manufacturing.
Key Responsibilities:
- Collaborate effectively with cross-functional teams in a collaborative environment.
- Act as the quality representative on new product development teams.
- Review documentation and specifications tied to drawings or purchase orders, highlight concerns, and communicate effectively with the development team to ensure smooth project transitions into production.
- Take the initiative to foresee project needs and develop strategic plans to mitigate risks.
- Respond promptly and professionally to both internal and external quality-related inquiries.
- Maintain compliance with FDA, ISO, and government regulations.
- Design and optimize validation protocols and create reports to satisfy regulatory, customer, and internal production standards.
- Develop detailed inspection plans, fixtures, and methods to meet quality expectations while documenting identified quality issues and enforcing best practices.
- Coordinate with the metrology team on first article inspections and capability studies, ensuring data accuracy for submission to clients.
- Investigate product quality issues to determine root causes and implement corrective solutions, assisting in the corrective action process as needed.
- Manage priorities across multiple projects of varying complexity, aligning with new product development timelines.
- Drive continuous improvement in procedures, processes, compliance with standards, and overall product quality.
- Provide insights and support to Sustaining Engineers and assist with production challenges as necessary.
- Conduct internal audits as per the scheduled plan.
- Mentor junior team members on quality and project-related matters, fostering their professional growth and ensuring timely issue resolution.
- Identify any gaps in existing equipment or resources and propose solutions to strengthen the quality team's responsiveness to changing market demands.
Salary Range: $95,000 - $140,000
