Centerline Biomedical · 3 hours ago
Quality Engineer
Cleveland, Ohio
Full-time
Onsite
Entry, Mid Level
1+ years expCenterline Biomedical is focused on maintaining and improving quality systems in accordance with industry standards. The Quality Engineer will be responsible for supporting complaint investigations, conducting quality audits, and ensuring compliance with quality metrics and standards while collaborating with cross-functional teams.
BiotechnologyHealth CareMedicalNavigation
Responsibilities
Participate on cross-functional new product development teams with focus on the execution of quality plans and design transfer
Perform quality audits and/or inspections
Develop and implement statistically valid sampling plans, design of experiments, capability studies, SPC and trend analysis
Lead and/or participate in process and product corrective actions and problem-solving activities
Constantly review the current quality system and recommend / implement improvements as needed
Review collected data to perform statistical analysis
Participate on projects focused on quality system, product quality and service quality improvement
Collect data and prepare reports on the trends of the quality system key performance metrics
Participate/support external and internal quality system audits
Supports development and implementation of methods for sampling, inspection, testing and evaluation of products
Completes Supplier Corrective Action Requests (SCARs) and communicates with suppliers in regards to non-conformances, supplier changes, etc
Acts as lead on assigned CAPAs to drive corrective actions and closure of CAPA within prescribed timelines
Performs and documents customer complaint investigations, performs root cause analysis and develops corrective and preventive actions. Works with customers to provide required technical support and information regarding the investigation
Instruct other employees in updated procedures, quality principles, effective corrective actions, and/or valid statistical techniques
Collaborate with other departments and facilities within the company on quality related issues
Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials
Additional duties as assigned
Qualification
Required
Bachelor's Degree in Engineering or related technical field required
1-3+ years of combined Quality Engineering and/or Quality Systems experience
1-3+ years of experience working in an ISO certified environment required, ISO 13485:2016 preferred
Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint
Excellent problem-solving skills
Experience with root cause analysis tools
Experience working on cross-functional teams and on own initiative
Demonstrated excellent organizational, oral and written communications skills
Commitment to learn new skills and tools as they become relevant
Flexibility, self-starter, and ability to work in a diverse work environment dealing with multiple tasks with deadlines
Preferred
1-3+ years of experience with medical device or other regulated industries preferred
ISO 13485:2016 preferred
Experience with EO sterilization validation preferred
Company
Centerline Biomedical
Centerline Biomedical, a Cleveland Clinic spin-off, is developing an innovative system
11-50 employees
H1B Sponsorship
Centerline Biomedical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
Funding
Current Stage
Growth StageTotal Funding
$60.41MKey Investors
Cleveland ClinicNational Heart, Lung and Blood Institute
2022-06-27Series B· $33M
2020-04-21Grant· $1.5M
2020-03-10Series Unknown· $10M
Leadership Team
Jim Dillon
President & CEO
Vikash Goel
CTO | Operations ♦ Precision Care ♦ Health IT for Minimally Invasive Surgery ♦ Investor Relations
Recent News
2025-08-20
2025-04-02
Company data provided by crunchbase