Quality Engineer II

Integer Holdings Corporation; Quakertown (Bucks County); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, vision, disability, &

401(k) with company matching

Parental leave

Paid holidays

Training & development

Job summary

Integer Holdings Corporation is seeking a Quality Engineer to apply advanced quality tools in the medical device industry. You will resolve complex problems, adhere to QMS and FDA requirements, and support inspections, audits, and process improvements.

You will collaborate with manufacturing and engineering teams, review documentation, and contribute to CAPA activities while maintaining a strong focus on quality and regulatory compliance.

Qualifications

• Bachelor's degree in engineering or related field required; 3 years' relevant experience.
• Alternative: 7+ years of relevant experience if education requirement not met.
• Awareness of ISO, QSR and FDA regulations is preferred.
• Strong written and oral communication skills.

Responsibilities

• Lead generation and completion of protocols and reports for test method validations.
• Interface with Manufacturing Engineers to review processes and coordinate validations.
• Review BOM changes, assembly procedures and component specifications for accuracy.
• Participate in CAPA activities, data analysis, and root-cause investigations.
• Support regulatory inspections, audits, and compliance with QMS and safety requirements.

Skills

Written and oral communications

Technical aptitude

Problem solving

Collaboration

Education

Bachelor's degree in engineering or related field

7+ years relevant experience if education not met

Tools

Microsoft Office

Job description

Who are we?

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.

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. 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

How you will be measured: The specific measures listed below may be subject to change and are not intended to be an all-inclusive list. Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs. Adhere to all Integer Values: Customer, Integrity, Candor, Inclusion, Collaboration, Innovation You will have defined Goals and Objectives specifying key projects and expected milestones to achieve. Quality - Customer Direct Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time Innovation and ideation are critical aspects of your role, and you will be expected to generate continuous improvement suggestions and support the implementation of them.

What sets you apart:

Minimum Education: At a minimum you have earned a bachelor’s degree in an engineering or related field and 3 years relevant experience Candidates who do not meet the education requirement may be considered with 7+ years of relevant experience.

Specialized Knowledge: You will have awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) You will have good knowledge in Microsoft Office

Specialized Skills: You will demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual. You will demonstrate competencies in both written and oral communications. For outside of US countries, you will demonstrate competencies in both written and oral English communications You will maintain a calm demeanor that transcends the high energy, constantly changing production environment. You will possess a positive, can-do attitude with an underlying belief that failure is not an option.

Our total rewards program

Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy.

• medical, dental, vision, disability, life insurance, and 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.

Equal Opportunity Employer

U.S. Applicants: Equal Opportunity Employer.

In addition, veterans and individuals with disabilities are encouraged to apply.

Integer Holdings Corporation

Integer Holdings Corporation (“Integer”) is an equal opportunity employer.

We do not discriminate based on race, color, sex, religion, national origin, and on any other protected characteristics.

We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination.

Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active‑dut‑y wartime veteran, campaign badge veteran, referred to collectively as "Protected Veterans."

It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities.

All employment decisions are based only on valid job requirements.

This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment.

Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons.

Remote Eligibility

For remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington.