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
Who are we?
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. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.
Integer Spiddal, develop and manufacture implantable medical devices, as a contract manufacturer to many of the leading, global medical device companies. Our innovative technology focus and biomaterials expertise foster a dynamic culture, which delivers next-generation implantable solutions.
Integer facility is situated along the Wild Atlantic Way in Spiddal, overlooking the Galway Bay and is just 20 minutes from Galway City by car.
As we continue to grow and expand our facilities, we are looking for like-minded people to come and join our team.
What You'll Do In This Role
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, company policies and operating procedures, and other regulatory requirements.
The Process Development Quality Engineer is a designated quality role with responsibility for:
Providing quality support during the development and introduction of new processes prior to transfer to manufacturing for all PDP projects at the process development site(s).
Responsibilities
The roles & responsibilities of the PDP Quality Engineer are defined in the Phase Checklist FRM for all PDP projects. These responsibilities are documented in a RACI matrix format and include the following deliverables:
Manufacturing Quality Control Plans
Responsible for Developing and implementing quality control procedures to ensure product quality and consistency, compilation of all quality components defined as necessary for the manufacturing of a specific product and/or part. The control plan shall include identification of test methods, sampling plans and process controls required to assure that the product meets the requirements and customer expectations.
Development of the Master Validation Plan
The PD Quality Engineer will work as part of the new product introduction team in the development of the Master Validation Plan with primary responsibility for defining the test method validation required as part of the plan.
New Product TMV Assessment for Manufacturing
Creation of manufacturing test method procedures prior to transfer to production. Generating Test method Protocols and Reports for approvals per PRO
Completing the Quality build plan, generating the CoC and documenting/collecting the build notes, as applicable, and reviewing the product build documentation to ensure compliance with customer and Integer requirements.
Manufacturing Test Method Validation Protocol/Report (s)
Facilitators, owners, and authors of TMV documentation for TMV requirements identified for products in production or when designated. Responsible for defining the TMV requirements for these test methods. Review and approval of relevant TMV documents as required per PRO
Sourced Item Qualifications
Responsible for managing the sourced item qualifications, defining key characteristics, determining testing requirements and developing new test methods as needed. Following up on any conditionally approved sourced item qualifications prior to production release, and ensuring all appropriate documentation is completed. Performing Qualifications, Reviewing for Acceptance, Acceptance Criteria, First Article Inspection for Non-Key Characteristics.
Developing & Creating pFMEA with the wider team
Conducting risk assessments and failure mode and effects analysis (FMEA) to identify and mitigate potential issues.
Manufacturing Documentation
Work in conjunction with the team to develop and release work instructions and support documentation for the new product.
Process Validation Protocol / Report (s)
Ensuring compliance to applicable standards and Integer procedures. Owning the measurement equipment and ensuring all necessary test methods and test/measurement equipment are developed, qualified, and approved prior to use. Ensuring all required equipment is in a state of calibration and on the calibration system through Installation Qualification. Reviewing and approving all relevant validation documents as required per PRO
Assess and determine the acceptance criteria required for each process step based on the output of the pFMEA in conjunction with the new product introduction team.
Post validation, ensure that the appropriate level of process monitoring is implemented dependent on the level of capability demonstrated during the process qualification.
Certificate of Conformance
PD Quality Engineer creation and review/approval of CoC for development products.
Work Order Review and approval
– Preapproval of W/O and Final Approval prior to shipment.
Additional Responsibilities Are As Follows
Support Non-Conforming Material Process (New Products):
* 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 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.
* Support Notified Body / Regulatory Agency / Customer Audits.
* 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 journey to differentiated quality.
* 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:
* You have earned, as a bachelor's degree, minimum, 3-year degree in an engineering or related technical/ Science field. Candidates who do not meet the education requirement may be considered with 5+ years of relevant experience. Combination of relevant experience and technical degree could be allowed.
* Minimum Experience:
* 1-2 years of experience as a Quality Engineer.
* Specialized Knowledge:
* You will have awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDR etc).
* Previous validation and new product introduction experience is highly desirable.
* Ability to analyze statistical date in Minitab
* 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.
* Knowledgeable in the use of measurement equipment (examples: Vernier's, micrometers, durometers, etc.). Experience with Vision-based inspection systems (examples: Smartscopes, Tagarno, Tensile Testers).
* Understand the requirements of calibration procedures, review of relevant documentation and certifications relating to equipment/tooling.
* Evaluates, selects, and applies GMP and GDP good standard manufacturing practices, techniques and procedures while using sound judgment when making decisions regarding material, product and documentation compliance.
* 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.
* Demonstrated 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.
* Great attention to detail
* Good Team player
U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.