Cork Medical · 18 hours ago
Quality Engineer - II
Indianapolis, IN
Full-time
Hybrid
Entry, Mid Level
$80K/yr - $80K/yr
2+ years expCork Medical is a growing medical device company that designs and manufactures innovative negative pressure wound therapy solutions. As a Quality Engineer II, you will be a key technical expert responsible for advanced quality assurance functions, leading investigations, and ensuring compliance with regulatory expectations across various departments.
Health CareManufacturingMedical Device
Responsibilities
Lead complaint investigations, determine regulatory reportability, and implement corrective and preventive actions
Mentor teams on root cause analysis and drive effectiveness checks for CAPA closure
Oversee calibration and preventive maintenance programs
Support manufacturing engineering with qualification protocols (IQ/OQ/PQ), deviations, risk assessments, and change control activities
Contribute to the Validation Master Plan and ensure all qualification documentation is audit-ready
Conduct supplier audits and evaluate supplier performance
Support internal/external audits (FDA, ISO, MDSAP) and monitor key quality metrics
Oversee incoming, in-process, and final inspections
Analyze inspection data, investigate nonconformances, and drive timely resolutions
Lead MRB meetings and ensure NCRs are thoroughly documented and closed
Ensure cleanroom compliance, monitor bioburden/particulate results, and review sterility testing
Collaborate with Manufacturing to reduce scrap and rework while improving yield
Maintain controlled documentation and support ongoing operator training
Ensure complete documentation and timely closure of deviations
Assess impact on quality, safety, and compliance while coordinating cross-functional responses
Qualification
Required
Bachelor's degree in Engineering and/or related field or experience
Experience in quality engineering within medical devices
Strong knowledge of ISO 13485, FDA regulations, CGMP, and quality system methodologies
Experience with an electronic QMS
Experience with processing trends and tracking
Excellent communication skills and the ability to work collaboratively across teams
Strong analytical mindset and the ability to interpret complex technical data
Proficiency with Microsoft Office and quality tools
Preferred
Experience with CAPA and Quality Supplier control is a plus
Bachelor's (Preferred)
Medical Device : 2 years (Preferred)
ISO 13485: 2 years (Preferred)
FDA regulations: 1 year (Preferred)
CGMP: 2 years (Preferred)
Benefits
401(k)
401(k) matching
Dental insurance
Employee assistance program
Flexible schedule
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Referral program
Tuition reimbursement
Vision insurance
Company
Cork Medical
Cork Medical manufactures wound care products, including specialty mattresses, wheelchair cushions, and negative pressure wound therapy.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Brian Karns
Chief Operating Officer
Matt Effinger
Chief Revenue Officer
Recent News
GlobeNewswire News Room
2025-07-09
Company data provided by crunchbase