Integer Holdings Corporation · 12 hours ago
Senior Quality Engineer
Minneapolis, MN
Full-time
Onsite
Senior LevelInteger Holdings Corporation is committed to creating a unified culture that embraces uniqueness and positions the company for long-term success. The Senior Quality Engineer will ensure compliance with safety and quality requirements, lead product and process improvement initiatives, and provide technical support to other Quality Engineers.
Health CareManufacturingMedicalMedical Device
Responsibilities
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. To participate in Technical reviews for Process development
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 and 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 and Control plans
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
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
Performs other functions as required
Opportunity to lead Quality Technical also available for interest in people management Career Path
Qualification
Required
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. To participate in Technical reviews for Process development
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 and 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 and Control plans
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
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
Performs other functions as required
Opportunity to lead Quality Technical also available for interest in people management Career Path
Strong Statistical techniques, Use of RCA approaches to deliver sustained improvements, Excellent Workload management to complete projects in a timely manner and Good Soft skills to interact and work with Key stakeholders to provide collaborative solutions
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.
Founded in 2000
10001+ employees
H1B Sponsorship
Integer Holdings Corporation 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
2025 (1)
2024 (3)
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
Company data provided by crunchbase