Quality Engineer II- Spiddal Galway

Integer Holdings Corporation; Spiddal; On-site; EUR 55,000 - 75,000; Full time

Job summary

Integer Holdings Corporation seeks a Quality Engineer to support design and manufacturing quality in the medical device sector. You will apply advanced quality tools, ensure compliance with QMS, FDA and ISO standards, and collaborate with cross-functional teams to resolve issues and drive CAPA improvements.

You will review changes, develop test methods, support inspections, and maintain device history records while upholding Integer Values: Customer, Integrity, Candor, Inclusion, Collaboration,

Qualifications

• Bachelor's degree in engineering or related field is required.
• 3+ years of relevant experience in quality engineering or medical devices is preferred.
• Familiarity with ISO, QSR, UL, FDA regulations and QMS is essential.

Responsibilities

• Manufacturing support: assist regulatory inspections and inquiries.
• Review BOM changes, assembly procedures, and DFM/DFMEA docs.
• Lead test method protocols and validation reports.
• Support CAPA activities and non-conforming material processes.
• Collaborate across teams to ensure product quality and process improvements.

Skills

Regulatory knowledge

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Tools

Microsoft Office

Job description

Our Values

• 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?

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. 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.

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:

• 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 While you will have regular support and guidance from more experienced engineers, supervisors or managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.
• 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.
• #IND1 U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.
• 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. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company's brands include Greatbatch Medical® and Lake Region Medical®.

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

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