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

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 Minitab

MINIMUM 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 position

PHYSICAL & 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.