Senior Quality Engineer

JCW Group; Minneapolis, Saint Paul (MN, MN); On-site; USD 100,000 - 115,000; Full time

Job summary

A leading company in the medical equipment manufacturing sector is seeking a Quality Engineer to manage quality processes and enhance product performance. The role involves significant collaboration across teams, technical documentation, and ensuring compliance with regulatory standards. Ideal candidates will possess strong technical writing skills and a solid background in quality assurance and process validation.

Qualifications

• 5+ years of experience in quality engineering within the medical device industry.
• Hands-on experience with validation (IQ/OQ/PQ) in a regulated environment.

Responsibilities

• Manage and execute the change control process.
• Lead process validation activities for new equipment.
• Provide technical writing support for documentation.

Skills

Technical writing

Statistical techniques

Manufacturing process controls

Change control

FDA QSR

ISO 13485

GMP standards

Collaboration

Tools

Windchill PLM

Job description

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No C2C or 1099 contractors will be considered

Key Responsibilities:

• Manage and execute the change control process in accordance with site-specific and corporate quality system procedures
• Lead and support process validation activities, including OQ and PQ, particularly for new and modified equipment implementations
• Collaborate closely with cross-functional teams to implement and support manufacturing process optimizations
• Provide technical writing support for validation protocols, engineering studies, and change documentation
• Apply statistical techniques to process analysis, validation, and improvement efforts
• Partner with stakeholders to gather background and requirements for current and upcoming improvement projects
• Supervise and review outputs related to product quality and performance to ensure compliance and effectiveness
• Participate in the execution of pre-drafted improvement projects and ensure deliverables meet internal and regulatory standards
• Interface with oversight engineers and site leads to ensure project alignment and success

Top Qualifications & Skills:

• Strong technical writing skills for documentation, protocols, and reports
• Proficiency in statistical techniques
• Solid understanding of manufacturing process controls and process capability
• Hands-on experience with change control and validation (IQ/OQ/PQ) in a regulated environment
• Knowledge of FDA QSR, ISO 13485, and GMP standards
• Experience with Windchill PLM is preferred
• Strong cross-functional collaboration and communication skills

Preferred Background:

• 5+ years of experience in quality engineering within the medical device industry
• Prior involvement in equipment validations, process improvements, and manufacturing quality projects

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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