Integer Holdings Corporation · 5 hours ago
Senior Quality Engineer
Trenton, GA
Full-time
Onsite
Mid, Senior Level
$119K/yr - $119K/yr
7+ years expInteger Holdings Corporation is committed to creating a culture that unifies and embraces uniqueness for long-term success. They are seeking a Senior Quality Engineer to provide support for Operations in ensuring adherence to Quality System requirements for medical device manufacturing while leading product and process improvement initiatives.
Health CareManufacturingMedicalMedical Device
No H1B
Responsibilities
Provide support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance
May provide work direction for 3-5 Engineers / Technicians / Inspectors
Adheres to GB Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS),U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements
Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality
Ability to interpret drawings, product/performance specifications, and other systems integration technical data
Monitors manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained
Leads product and process improvement initiatives
Implements various product and process improvement methodologies
Reviews the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc
Leads in the development, completion, and maintenance of risk analyses
Leads generation and completion of protocols and reports for product, process, and test method validations
Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable
Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures
Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence
Leads and manage complaint investigations and remediation recommendations as needed
Leads plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis
Assists with product transfers
Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems through capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc
Provides technical support to and work direction other Quality Engineers as needed
Qualification
Required
Bachelor's degree in Engineering, Mathematics or Statistics, or related (or its equivalent)
7 years' experience in a manufacturing environment as a technician or engineer
5 years' experience with 21 CFR 820: Process complaints, Drive CAPAs, Conduct structured problem solving including 5-why, 8-D and Fishbone diagrams
Use of Minitab and ETQ Reliance
Technical Writing (including work instructions) and validation documents
2 years' experience in Medical Device manufacturing ISO 13485 standards
Benefits
Medical
Dental
Vision
Disability
Life insurance
Adoption benefits
Parental leave
Supplemental life insurance
Critical illness
Hospital indemnity
Accident insurance
401(k) plan with company matching contributions
80 hours (10 days) of company designated holidays per year
Annual allotment of paid time off
Company
Integer Holdings Corporation
Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$1.44BKey Investors
Disruptive Technologies Innovation Fund
2025-09-25Grant
2025-03-13Post Ipo Debt· $1B
2023-01-31Post Ipo Debt· $435M
Leadership Team
Payman Khales
President and CEO
Recent News
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