NPI Quality Engineer II- Spiddal Galway

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




The primary purpose of this position is to perform work which involves general engineering methods and tools associated with New Product Introduction (NPI) projects. You will be utilizing more advanced quality/engineering tools and concepts while developing your role as a NPI engineer in the medical device industry. You apply engineering concepts to resolve acute or chronic problems encountered in the projects that you will support. 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.

NPI 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 assist under minimum supervision in the development of new test methods and in the improvement of existing methods including design and manufacture of new tooling, fixtures, and templates.

· Assist under minimum supervision in the testing and validation of new test methods including gage R&R studies and statistical analysis of data through software packages such as Minitab.

· Under minimum supervision, update test method procedures and product/process related standard operating procedures as required.

· Provide technical input into root cause analysis. Generate investigation reports within KPI metrics and timelines and route for approval. Participate and provide technical input on cross functional reviews for the projects you are supporting.

· You will review procedures, protocols, reports, and other documents related to test method development, product testing and process validation associated with new product introduction.

· You will be a member of a Cross Functional Project Team, providing expertise for development of NPI projects. Participate and provide technical input in line with the product development process (PDP) and associated procedures.

· Ensure compliance at all stages of product development process (PDP).

· Support planning execution of design verification & validation activities.

· Support planning execution of risk management activities per ISO14971.

· Under minimum supervision, carry our periodic reviews of internal and external standards and identify potential gaps which require action.

· 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

• Systems & Process Optimization through adoption of principles of built-in-quality.

· Specialized Knowledge:

o You will have awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)

o You will have good knowledge in Microsoft Office

o 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:

o 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.

o You will demonstrate competencies in both written and oral communications.

o For outside of US countries, you will demonstrate competencies in both written and oral English communications.

o You will maintain a calm demeanor that transcends the high energy, constantly changing production environment.

o You will possess a positive, can-do attitude with an underlying belief that failure is not an option.

o You will be required to have a good working knowledge of Statistics and use of Minitab.

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U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.