Quality Engineer II — Medical Device, Onsite Problem Solver

Real; Maple Plain (MN); On-site; USD 75,000 - 120,000; Full time

Job summary

Specialist Staffing Group is seeking a Quality Engineer II for a fast-growing orthopaedic medical device startup in Maple Plain, MN. You will own manufacturing quality objectives, provide hands-on support for sterile processes, and lead CAPA across cross-functional teams to drive robust, scalable quality improvements.

The role emphasizes practical problem-solving on the manufacturing floor, escalation of high-risk issues, and alignment with quality policies to ensure patient safety and product

Qualifications

• Bachelor's degree required with 2+ years of related experience.
• Experience independently leading investigations or corrective actions.
• Self-starter who can manage responsibilities with limited supervision.

Responsibilities

• Own manufacturing quality objectives for product performance and process control.
• Provide hands-on quality support for sterile packaging and sterilization processes.
• Lead investigations and CAPA for nonconformances, process issues, or supplier quality.
• Lead cross-functional quality and continuous improvement projects on the floor.
• Embed quality requirements into new and expanding production lines and changes.
• Monitor supplier quality and support supplier corrective actions.
• Apply inspection methods and use drawings, specs, and sampling plans to govern quality decisions.
• Provide guidance to less experienced team members and escalate high-risk issues.
• Maintain quality records and ensure compliance with policies and regulatory requirements.

Skills

Indepth investigations

Lean quality

Cross-functional collaboration

Quality leadership

Document control

Education

Bachelor's degree

Tools

Measurement tools

Job description

Specialist Staffing Group is seeking a Quality Engineer II for a fast-growing orthopaedic medical device startup in Maple Plain, MN. You will own manufacturing quality objectives, provide hands-on support for sterile processes, and lead CAPA across cross-functional teams to drive robust, scalable quality improvements.

The role emphasizes practical problem-solving on the manufacturing floor, escalation of high-risk issues, and alignment with quality policies to ensure patient safety and product