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 Engineer III Quality coordinates the continuous quality improvement, in-process inspection and finish product release activities. Supports to Production and Engineering teams in day-to-day Operations. Supports NPI with Validation activities. Monitors the Quality KPI's and leads the team efforts for the continuous improvement of these metrics.
MAIN RESPONSABILITIES:
- Develop and coordinate Validation Plans and Risk Assessment activities.
- Develop test method validations and related documentation.
- Coordinates the execution of inspection/test plans for validation projects.
- Support with statistical analysis and experiments design as needed by the manufacturing operation or new products development.
- Monitors the Quality KPI's and leads the efforts to meet the targets and continuous improvement of these metrics (CAPAS, NCMR, Complaint Reports, etc.).
- Support and guide the team with the CAPA Activities.
- Support the Internal and external audits.
- Supervise Quality Technicians/Inspectors and coordinates their activities to ensure continuous support to the manufacturing operations.
- Support with other activities as required by TJN Quality Management.
JOB REQUIREMENTS
- Bachelor’s Degree in Engineering or related field required.
- 5-7 years’ experience in medical device or regulated manufacturing
Specialized Knowledge:
- Competence in the selection and use of Quality Engineering Tools and Techniques.
- Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
- Proficient in Microsoft Office and Minitab
Special Skills:
- Ability to work independently and in team environment.
- Ability to effectively communicate written and verbally.
- Ability to manage time effectively to ensure timely completion of tasks
- Knowledge of SPC, FMEA, DOE, RCA, GDT Sound knowledge of quality management systems.
Other:
- Certified Quality Engineering (CQE)
- Certified Software Quality Engineer (CSQE)
- Certified Reliability Engineer (CRE)
- Certified Quality Auditor (CQA)
- Certified Biomedical Auditor (CBA), or Six Sigma Green Belt or Black Belt desired.
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.
