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Npi Quality Engineer- Parkmore Galway

4 weeks ago

Galway, Galway, Ireland Integer Holdings Corporation Full time

NPI Quality Engineer- Parkmore Galway page is loadedNPI Quality Engineer- Parkmore GalwayApply locations Galway, Ireland time type Full time posted on Posted Today job requisition id R32057By 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
JOB SUMMARY The New Product Introduction Quality Engineer will primarily be responsible for providing quality support for all product development projects at the Integer Galway site, ensuring compliance to Integers quality system and product development process procedure.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES Employees are expected to support the quality concepts inherent in the business philosophies of Integer, including a variety of job-related tasks which may not be specific to this position profile.
Accountabilities include: Developing and maintaining world class quality systems related to the manufacture of components and finished medical devices.Key member of project team providing Quality support and expertise for new product projects for both NPI & R&D groups as required.Ensure compliance at all stages of product lifecycle development process.Ensure quality of new products as defined in customer specification.Test method development and validation.Gage R&RAttribute Agreement Analysis'.SOP Writing.Provide key role in validation activities & projects including:Guidance & Input to process/product validation activities including IQ/OQ/PQ.Guidance in validation protocol development.Supporting Engineering function to ensure compliance to related element of quality system.Detailed Review & Approval of validation protocols & Reports.Provide quality support for customer related quality requests ensuring customer expectations are met in a timely manner and to a high standard.Develop new product process control plans and quality plans as required.Engineering Change Order (ECO) and change records process review & approval.Provide detailed review, input, and approval of product development process project deliverables.Execute Sourced item qualifications and first article inspections (FAI) ensuring suppliers understand expectations for producing sourced items consistently during development and production.Provide quality technical and compliance support for new product and manufacturing related issues.Ensure all process variables and their interactions are adequately defined, ensure all failure modes in process have been identified and provide input into FMEAs.Support, NCR, CAPA analysis & Problem solving as required.Playing a role in the plant annual objectives.Ensure continued compliance with all Regulatory Standards including ISO-13485.SKILLS AND KNOWLEDGE: Knowledge of Statistical techniques including Gage R&R & Process Capability.Ability to communicate and work with people inside and outside the department.Good communicator (written and oral).Ability to train and lead.Ability to co-ordinate, plan and organise in a timely manner.Knowledge of engineering theories and methods.Ability to understand engineering drawings.Good technical report writing skills.Rigorous attention to detail.Experience in MinitabMINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS: Engineering or science Degree preferably with Quality Engineering included or sufficient experience in a similar medical devices role.Minimum 3 years experience in a similar positionPHYSICAL & MENTAL DEMANDS. Work effectively with close tolerances in a fast paced demanding environment.REPORTING RELATIONSHIP AND PRESENCE OF SUPERVISOR. This position reports directly to the Design Assurance Manager.U.S.
Applicants: Equal Opportunity Employer.
In addition, veterans and individuals with disabilities are encouraged to apply. About UsInteger Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets.
The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide.
In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets.
The company's brands include Greatbatch Medical, Lake Region Medical and Electrochem.
Additional information is available at .
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-duty 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.
If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at +716-759-5631 or via ****** so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening.
This phone number and email address is strictly for the purpose of making a request for an accommodation.
Status updates on your application cannot be provided to you through this phone extension or email.
For status updates, please log in to postings presume all work will be performed entirely outside of California, Colorado, Connecticut, Hawaii, Illinois, Maine, Maryland, Montana, Nevada, Rhode Island, Vermont, and the State of Washington, and outside of the municipalities of Jersey City, NJ, and Washington D.C.
In addition, all work performed for remote eligible positions will be performed outside of Minnesota, and outside of New York State unless the supervisor of that position is also based in New York State.
To review the Integer U.S.
Applicant Privacy Statement click here .

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