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 Quality Engineer will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls.
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:
- Ensure continued compliance with all Regulatory Standards. This includes:
- ISO 13485 & MDSAP
- ISO 14000
- Ensuring continued compliance with Quality Plans and Risk Management Documents.
- Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
- Trend analysis of data from the controls
- Potential improvements for review with engineering based on the trends.
- Areas for Improvement to senior management.
- Review and propose changes to sampling plans based on trend analysis and changes to the system.
- Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements.
- Support the NCR meetings to ensure that internal and customer concerns are handled and dealt with in an appropriate manner.
- Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner.
- Validations.
- Change Requests and Document Revisions
- Non Conformance Reports
- Internal Audits.
- Failure Mode Effect Analysis (FMEA).
- Deviation Requests
- Project meeting attendance as required.
- Attend and participate in daily cell meetings.
- Preparation of information for KPI and Management Review meetings.
- Be an active member of the Integer New Ross team and work with all employees to develop a world class lean manufacturing system.
- Comply with the Integer behavioural standards.
SKILLS AND KNOWLEDGE:
- Ability to communicate and work with people inside and outside the department.
- Good communicator (written and oral).
- Ability to train and lead where required.
- Ability to co-ordinate, plan and organise in a timely manner.
- Knowledge of Statistical and Quality Improvement methods
- Good technical report writing skills.
- Rigorous attention to detail.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
- Degree with strong engineering, science or quantitative content
- Experience in analysis and reporting using Minitab, Power BI or equivalent would be an advantage.
- Education requirement can be substituted by strong experience as quality engineer or technician.
U.S. Applicants: EOE/AA Disability/Veteran
Top Skills
What We Do
Integer Holdings Corporation (NYSE:ITGR) is a leader in advanced medical device outsourcing (MDO) and serves its customers by providing comprehensive end-to-end solutions with its unparalleled expertise in innovation and manufacturing. Integer's vision is to enhance the lives of patients worldwide by being its customer's partner of choice for innovative medical technologies and services. Additionally, through Electrochem, an Integer company, it develops custom batteries for high-end niche applications in energy, military, and environment markets. The company's medical device manufacturing brands include Greatbatch™ Medical and Lake Region Medical™. Additional information is available at www.integer.net.
