Manufacturing Quality Engineer

Description:

Primary Talent Partners is hiring a highly skilled Manufacturing Quality Engineer II for a 12-month contract with one of its leading medical device clients based in Plymouth, Minnesota. This position provides an excellent opportunity to work with a world-class organization focused on innovation, precision, and quality in the medical manufacturing sector.

The Manufacturing Quality Engineer II will play a critical role in developing, implementing, and maintaining quality systems, ensuring that materials and products consistently meet required standards. The role will involve close collaboration with engineering, manufacturing, and quality assurance teams to uphold regulatory compliance and drive continuous process improvement across production lines.

Key Responsibilities:

• Quality Standards Development: Establish, modify, and maintain quality protocols for processing raw materials into finished or semi-finished products.

• Cross-Functional Collaboration: Partner with engineering and manufacturing teams to ensure quality control systems are properly integrated into all production processes.

• Inspection & Testing: Design and implement inspection and testing methods to assess precision, reliability, and product performance.

• Equipment & Process Validation: Specify, evaluate, and maintain inspection and testing mechanisms or equipment to ensure consistent production accuracy.

• Data & Root Cause Analysis: Conduct statistical analysis to determine causes of non-conformance, evaluate cost impact, and assign accountability for quality deviations.

• Corrective Actions: Ensure corrective and preventive measures align with reliability standards and comply with documentation and regulatory requirements.

• Specialized Focus: May work in specialized areas such as design validation, incoming material inspection, production control, inventory quality, or R&D quality processes.

• Project Management: Deliver assigned projects independently, contributing to project objectives, milestones, and process improvements.

• Mentorship: Provide guidance and support to junior engineers or support staff when needed.

Required Knowledge, Skills, and Abilities:

• Strong understanding of manufacturing quality systems, statistical process control (SPC), and root cause analysis methods.

• Familiarity with FDA regulations, ISO 13485, and other relevant medical device quality standards.

• Excellent problem-solving, analytical, and decision-making abilities.

• Competence in using quality and engineering software tools for data collection, analysis, and reporting.

• Ability to communicate effectively across cross-functional teams.

• Self-driven professional capable of working independently with general supervision.

Educational Requirements:

• Bachelor’s Degree in Engineering (Mechanical, Biomedical, Industrial, or related discipline) from an accredited institution.

• Minimum of 2 years of relevant experience; candidates with an advanced degree may qualify with less or no direct experience.

About the Organization:

Primary Talent Partners is a trusted staffing and workforce solutions firm specializing in connecting talented professionals with leading organizations across industries. The company prides itself on fostering diversity, inclusivity, and excellence in the workplace.

Through its partnerships with high-profile clients in fields such as medical devices, engineering, technology, and manufacturing, Primary Talent Partners offers professionals the opportunity to contribute to meaningful projects while advancing their technical expertise and career development.

Equal Opportunity Statement:

Primary Talent Partners is an Equal Opportunity / Affirmative Action Employer committed to diversity and inclusion in the workplace. All qualified applicants will be considered without discrimination based on race, color, religion, gender, sexual orientation, age, national origin, disability, veteran status, or any other protected characteristic.

Applicants requiring accommodation during the application or hiring process due to a disability may contact info@primarytalentpartners.com for assistance.