Quality Engineer II

integer; Quakertown (Bucks County); On-site; USD 70,000 - 90,000; Full time

Job summary

Integer is a global organization delivering innovative technologies and manufacturing to Medical Device OEMs, focused on quality and patient outcomes. The role supports regulatory inspections and the control of design and manufacturing quality to meet FDA and QMS requirements.

You will drive test method validation, process improvement, and CAPA activities while collaborating with cross-functional teams to uphold Integer's quality standards across manufacturing and product transfers.

Qualifications

• General engineering methods and quality tools are used to resolve issues.
• Knowledge of Quality Management Systems (QMS) and FDA regulations.
• Experience with process validation, DOE, and CAPA is a plus.

Responsibilities

• Support regulatory inspections, audits, and deviations while ensuring compliance with DMR and quality records.
• Lead creation and validation of test protocols and reports; coordinate process validations.
• Resolve non-conforming material issues; drive corrective actions and root cause analysis.
• Collaborate across teams to sustain site quality activities and drive continuous improvement.

Skills

Quality engineering

Regulatory compliance

Process improvement

Root cause analysis

Cross-functional teamwork

Tools

QMS software

CAPA management

Statistical analysis

Job description

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long‑term success. At Integer, our values are embedded in everything we do.

Customer

We focus on our customers' success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

Who are we?

Integer is a global organization providing innovative, high‑quality technologies and manufacturing to Medical Device OEM's (original equipment manufacturers) to enhance the lives of patients worldwide and a provider of high‑end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.

What you'll do in this role:

The primary purpose of this position is to perform work which involves general engineering methods and tools. You will now be utilizing more advanced quality tools and concepts while developing your role as a quality engineering the medical device industry. You apply engineering concepts to resolve acute or chronic problems. You will ensure Integer internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization.

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.

Manufacturing Support:

• 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.

Create Test Methods:

• 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.

Support Non-Conforming Material Process:

• 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.

Support Site Quality Activities:

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.

Support Integer's Manufacturing Excellence and Market Focused Innovation Strategies:

Strategy Alignment through Site Hoshin Plans, Quality Plans, Validation mas