Integer Holdings Corporation · 19 hours ago
Quality Engineer II
Alden, NY
Full-time
Onsite
Mid Level
$70K/yr - $103K/yr
3+ years expInteger Holdings Corporation is a global organization providing innovative technologies and manufacturing to Medical Device OEMs. The Quality Engineer II role involves utilizing advanced quality tools to meet customer expectations, support regulatory inspections, and ensure product integrity throughout the manufacturing process.
Health CareManufacturingMedicalMedical Device
Responsibilities
You adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements
You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality
You will monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained
You will review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc
You will participate in continuous improvement projects
You will assist with product transfers
You will perform work on technical projects where you will follow Integer’s standard quality management and production system methodologies to investigate opportunities for product and process improvements
You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer
You will Lead the generation and completion of protocols and reports for test method validations
You will interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable
You will develop 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
You will ensure that the disposition of non-conforming materials meet all necessary procedures and assure adequacy of corrective actions to prevent re-occurrence
You will lead and manage complaint investigations
You will participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis
You will apply standard data analysis practices and observe products and processes to establish root cause for product and process failures or to support the justification for improvements to products and processes
You will support internal quality audit activities, as applicable
You embed Quality– “I own Quality.” You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), supporting to corrective and preventive actions investigation and implementation, and contributing to the successful attainment of our quality KPI’s and journey to differentiated quality
You may perform other duties as needed and as directed by your line of supervision
Support Integer’s Manufacturing Excellence and Market Focused Innovation Strategies: Strategy Alignment through Site Hoshin Plans, Quality Plans, Validation master plans, associated quality improvement imperatives, and regular updates to QA RA weekly and monthly metrics, supporting the walk to 5 sigma
Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required
Standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable
Associate Engagement promoted through the adoption of standardized problem solving methodologies, behavior-based safety programs, and improvement idea and suggestion systems
Systems & Process Optimization through adoption of principles of built-in-quality
Qualification
Required
Bachelor's degree in an engineering or related field and 3 years relevant experience
Awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
Good knowledge in Microsoft Office
Ability to work independently as well as collaboratively with other associates and cross functional teams
Solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual
Competencies in both written and oral communications
Competencies in both written and oral English communications for outside of US countries
Maintain a calm demeanor that transcends the high energy, constantly changing production environment
Possess a positive, can-do attitude with an underlying belief that failure is not an option
Benefits
Medical
Dental
Vision
Disability
Life insurance
Adoption benefits
Parental leave is available after one year.
Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance.
Employees are immediately eligible to participate in the 401(k) plan with company matching contributions.
We provide 80 hours (10 days) of company designated holidays per year plus an 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
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