Elucent Medical Inc. · 2 days ago
Quality Specialist
Eden Prairie, MN
Full-time
Onsite
Senior Level, Lead/Staff
$80K/yr - $90K/yr
10+ years expElucent Medical is a medical device company focused on developing surgical navigation technologies. The Quality Specialist leads quality activities for medical device development and manufacturing, performing quality engineering tasks such as data collection, statistical analysis, and authoring technical documentation.
Health CareMedicalOncology
Responsibilities
Independently author, review and approve complex quality protocols, validation plans and reports. Provide technical mentorship and ensure alignment with regulatory and organizational standards
Lead verification, validation and method development initiatives. Define test strategies, establish acceptance criteria, and interpret complex data to guide engineering decisions
Lead cross-functional teams to develop, optimize and implement quality SOPs and manufacturing/test instructions. Mentor junior technicians in document control and compliance practices
Design, execute and statistically analyze advanced measurement system analyses (e.g., Gage R&R , capability studies, DOE). Provide recommendations to improve measurement reliability and process control
Work from drawings, solid models, written and verbal descriptions or defined plans to perform testing and troubleshoot functions. Collaborate closely with design, manufacturing and quality engineering to proactively identify and resolve design for manufacturability and quality challenges
Apply advanced statistical tools (e.g., ANOVA, regression, SPC) to identify process trends and drive continuous improvement initiatives
Develop and maintain data reporting systems and dashboards. Translate data into actionable insights for product and process optimization
Lead root cause analyses and CAPA activities, developing corrective/preventive strategies. Provide technical guidance to teams to prevent recurrence and enhance product reliability
Ensure quality system documentation and record-keeping activities comply with established procedures and work instructions
Proactively identify opportunities for process and product improvement, driving initiatives to enhance operational excellence and compliance
Demonstrate safe work practices and maintain a clean, organized work area
Perform other duties as assigned by the manager
Qualification
Required
Associates or Technical degree with a minimum of 10+ years of progressively responsible experience in the medical device industry under ISO 13485 and related regulatory standards (FDA, QSR, EU MDR)
Demonstrated understanding of quality system principles, risk management and validation practices within regulated environments
Advanced math and analytical aptitude, with proven ability to apply statistical tools to support process capability, Gage R&R, and data-driven decision making
Proficient with digital tools and technical software, including Microsoft Office applications, Minitab, and Visio
Exceptional technical communication skills – able to author, review and approve quality protocols and technical summaries that meet internal and regulatory documentation standards
Experience providing cross-functional support to design, manufacturing, and quality engineering teams, including leading verification/validation activities, troubleshooting, and root cause analyses
Strong background in an electronics manufacturing, with a comprehensive understanding of electrical and mechanical testing methods and instrumentation
Demonstrated ability to mentor junior staff, lead quality initiatives and drive continuous improvement
Proven track record of independent problem solving, ownership of complex quality activities and consistent delivery of results in dynamic, highly regulated settings
Maintains a positive professional attitude when working with peers
Comfortable working in a self-directed team environment and giving or asking for instructions
Demonstrate an understanding of the medical device industry
Works effectively on cross-functional teams to establish appropriate processes pertaining to quality
The individual must have a hands-on approach
Strong organizational and time management skills
Ability to work on multiple tasks and projects with effectiveness and efficiency
Excellent written and oral communication skills
Positive and cooperative communications and collaboration with all levels of employees, contractors and suppliers
Ability to review, analyze, summarize and interpret data; draw conclusions and make appropriate recommendations and decisions
Benefits
401(k)
401(k) matching (4%)
Dental insurance
Health insurance
Vision insurance
Paid Holidays
Paid Vacation Days
Paid Sick Days
Short Term Disability
Long Term Disability
Life Insurance
Pet Insurance
Employee Assistance Programs
Company
Elucent Medical Inc.
At Elucent Medical, we’re pioneers in the realm of healthcare innovation, driven by a commitment to revolutionize patient care.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$92.1MKey Investors
Trinity Capital
2025-01-27Series Unknown· $30M
2024-04-10Series C· $42.5M
2019-07-01Series Unknown· $12M
Leadership Team
Jason Pesterfield
President, CEO & Director
Recent News
2025-02-07
Company data provided by crunchbase