Quality Engineer

The Quality Engineer II will support a high-visibility product development initiative within a design assurance or development quality team. This role provides quality engineering support across product development and manufacturing, with a focus on process validation, equipment qualification, manufacturing line support, risk management, and compliance with applicable regulatory and quality standards. The position partners closely with cross-functional teams to ensure patient safety, product quality, and business objectives are met.

• Support development, qualification, and ongoing manufacturing through effective process controls.
• Lead and support process validation and equipment qualification activities.
• Provide quality engineering support for manufacturing lines during new product development and scale-up.
• Apply structured problem-solving methodologies to identify, prioritize, and resolve quality issues.
• Ensure quality is built into processes by maintaining compliance with internal quality systems and regulatory requirements.
• Collaborate cross-functionally to support quality initiatives and continuous improvement efforts.
• Contribute to the development and execution of streamlined quality systems that drive issue identification and resolution.

• Bachelor’s degree with 2–4 years of experience, or Master’s degree with 0–2 years of experience.
• Hands‑on experience with process validation and equipment qualification
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• Experience providing manufacturing line support
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Mid‑Senior level

Contract

Quality Assurance

Medical Equipment Manufacturing