Quality Engineer

Strive Solutions; Germantown (TN); On-site; USD 65,000 - 90,000; Full time

Job summary

Strive Solutions is seeking a Quality Engineer II to support product quality and manufacturing readiness in a medical device environment. You will apply statistical methods and quality engineering practices to ensure robust processes and compliant products.

You will assist with validation activities, audits, and change management, working with customers and suppliers to resolve issues and drive continuous improvement across processes and products.

Qualifications

• Proficiency in statistical and quality engineering methods.
• Experience supporting validation and audit readiness in regulated environments.
• Strong problem-solving and root-cause analysis skills.
• Excellent collaboration and communication across teams and external partners.
• Strong understanding of quality systems and change management principles.

Responsibilities

• Apply statistical and quality engineering methods to support product quality and manufacturing readiness.
• Support validation activities and preparation for internal/external audits.
• Review product and process changes to assess impact on quality and compliance.
• Investigate quality issues and partner with customers, suppliers, and cross-functional teams to drive resolution.
• Contribute to continuous improvement efforts across processes and products.

Skills

Statistical methods

Quality systems

Audit readiness

Root-cause analysis

Cross-functional collaboration

Job description

Quality Engineer II supports product quality and new production introductions in a medical device manufacturing environment.

Key Responsibilities

• Apply statistical and quality engineering methods to support product quality and manufacturing readiness.
• Support validation activities and preparation for internal/external audits.
• Review product and process changes to assess impact on quality and compliance.
• Investigate quality issues and partner with customers, suppliers, and cross-functional teams to drive resolution.
• Contribute to continuous improvement efforts across processes and products.

Qualifications & Skills

• Proficiency in statistical/quality engineering tools and methods.
• Experience supporting validation and audit readiness in regulated environments.
• Strong problem-solving and root-cause analysis skills.
• Excellent collaboration and communication across teams and external partners.
• Strong understanding of quality systems and change management principles.