Overview
Senior Quality Engineer Jobs in Minnesota, United States at Invent Staffing
Title: Senior Quality Engineer
Company: Invent Staffing
Location: Minnesota, United States
Key Responsibilities:
Collaborate with new product development teams to support quality operations during the clinical manufacturing phase.
Assist in navigating the Edwards Quality Management System to produce test samples and early-use human product in alignment with project timelines.
Conduct and drive risk assessments on early-stage manufacturing processes (e.g., PFMEA, live manufacturing process reviews).
Lead test method validation efforts and develop improvements for in-process inspection methods.
Analyze and resolve complex compliance and manufacturing issues, including CAPAs, non-conformances, and audit observations.
Track and report on product yields and defect rates; present data in Quality Data Reviews to guide process improvements.
Oversee Material Review Board (MRB) activities, including disposition of potentially non-conforming human use products.
Support seamless product transfer from pilot operations to global receiving manufacturing sites.
Identify and implement manufacturing and inspection process optimizations.
Qualifications:
Bachelor’s degree in Engineering or related field with a minimum of 4 years of experience in the medical device industry; OR
Master’s degree in Engineering or related field with a minimum of 3 years of experience in the medical device industry.
Prior experience in medical device manufacturing or pilot operations strongly preferred.
Experience working with complex delivery systems or catheter-like devices is highly desirable.
Familiarity with Manufacturing Execution Systems (MES) is a plus.
Key Skills & Competencies:
In-depth knowledge of Quality Engineering principles, methods, and regulatory requirements (FDA, ISO 13485).
Strong problem-solving and analytical skills, with the ability to think critically and independently.
Skilled in statistical analysis and tools (Minitab experience preferred).
Excellent written and verbal communication skills with the ability to interact across all organizational levels, including senior leadership and cross-functional teams.
Detail-oriented with the ability to manage multiple competing priorities in a fast-paced, collaborative environment.
Proven ability to lead quality initiatives, influence decision-making, and drive continuous improvement efforts.
