Senior Quality Engineer

Elucent Medical•Eden Prairie, MN

44d•$115,000 - $125,000•Onsite

About The Position

The Senior Quality Engineer is responsible for reviewing and analyzing product quality data, manufacturing performance, field performance and reliability information using a strong technical and hands-on approach. The role actively leads product quality investigations across the product lifecycle, including nonconforming material investigations, field performance analysis, and complaint handling as an input to product quality improvement efforts. The role conducts detailed root cause investigations of product failures identified through internal production data, field returns and complaints and determines appropriate corrective and preventive actions that measurably improve product quality The position actively leads hand-on product investigations through testing, failure analysis, and development of technical test methods for electromechanical systems as well as sterile single-use medical devices sterile devices.

Requirements

5+ years’ experience as a Quality Engineer in the medical device industry.
BA/BS degree in science, engineering or technical field.
Demonstrated experience supporting single-use (disposable) medical devices and sterile products, including knowledge of validation, reliability, and lifecycle quality considerations.
Strong experience in product quality engineering, including nonconforming material investigations, field failure analysis, and CAPA leadership.
Working knowledge of FDA 21 CFR Part 820 (QMSR) and ISO 13485.
Proficient in statistical methods and advanced data analysis to support quality investigations and decision-making.
Strong computer skills, including data analysis tools, quality systems software, and standard business applications.
Hands-on, practical approach to problem solving, root cause investigations, and data-driven quality improvements.
Excellent organizational and time management skills with the ability to manage multiple priorities and meet deadlines.
Experience with electromechanical devices and systems required.
Demonstrated experience in complaint investigations, customer quality support, risk management, and data-based quality trending.
Experience generating quality documentation, including Quality Plans, validation protocols, and technical reports.
Recognized technical leader who maintains a positive and collaborative attitude when working with peers, customers, and suppliers.
Proven ability to lead product investigation teams and collaborate with internal and external stakeholders to resolve product quality issues.
Effective contributor on cross-functional teams to establish and improve quality processes.
Excellent written and verbal communication skills.
Ability to formulate clear, professional responses to customer inquiries, complaints, and regulatory agency requests.
Strong analytical skills with the ability to collect, review, analyze, summarize, and interpret data; identify trends; draw conclusions; make sound recommendations; prepare reports; and deliver presentations.

Nice To Haves

ASQ Certified Quality Engineer (Preferred)

Responsibilities

Lead product quality investigations in compliance with company procedures and applicable regulatory requirements.
Analyze field performance data, complaint data, and nonconforming product data to identify systemic quality risks and drive measurable product improvements.
Serve as process owner for product complaints, including reviewing, documenting, and investigating customer complaints to ensure accuracy, completeness, and proper regulatory reporting.
Drive timely completion of product investigations and corrective actions that improve product quality metrics, including reliability, defect rate, and field performance.
Lead nonconforming material investigations (NCMRs) and production quality investigations to prevent recurrence of product defects
Develop and lead validation and verification testing specific to electromechanical and sterile single-use devices.
Identify, analyze, and present product quality and reliability trends, including detection of systemic quality issues.
Develop and implement technical investigations and corrective actions to address quality problems and initiatives.
Lead product performance and reliability initiatives aimed at reducing complaint rates and enhancing product quality.
Apply knowledge of electrical and mechanical systems, including their interaction with software.
Provide leadership and technical input into product-related risk management and risk analysis activities.
Plan and conduct analysis of internal production performance to identify opportunities for process optimization and efficiency improvements.
Contribute to product safety, quality, and customer satisfaction decisions using data-driven and risk-based approaches.
Participate in and support Lead product quality investigations in compliance with company procedures and applicable regulatory requirements.