Quality Engineer III
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 Supplier Quality Management:
You will support Supplier Quality activities, both troubleshooting/CAPA and continuous improvement initiatives. You will work with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, assists each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc. Manufacturing Support:
You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. You will monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained. You will review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, pFMEAs, Control Plans, etc. You will participate in continuous improvement projects. You will assist with product transfers from NPD to Production You will perform work on technical projects where you will follow Integer's standard quality management and production system methodologies to investigate opportunities for product and process improvements. You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer. Create Test Methods:
You will support generate and completegeneration and completion of protocols and reports for test method validations. You will interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable. You will develop various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures. Support Non-Conforming Material Process:
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 lead and manage complaint investigations. You will participate and occasionally leadin 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 may be responsible to perform 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 5 Sigma. You may perform other duties as needed and as directed by your line of supervision. Minimum Education:
Bachelor's Degree in Engineering or related field required. Minimum
Experience:
5-7 years' experience in medical device or regulated manufacturing .
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
You will support Supplier Quality activities, both troubleshooting/CAPA and continuous improvement initiatives. You will work with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, assists each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc. Manufacturing Support:
You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. You will monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained. You will review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, pFMEAs, Control Plans, etc. You will participate in continuous improvement projects. You will assist with product transfers from NPD to Production You will perform work on technical projects where you will follow Integer's standard quality management and production system methodologies to investigate opportunities for product and process improvements. You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer. Create Test Methods:
You will support generate and completegeneration and completion of protocols and reports for test method validations. You will interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable. You will develop various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures. Support Non-Conforming Material Process:
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 lead and manage complaint investigations. You will participate and occasionally leadin 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 may be responsible to perform 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 5 Sigma. You may perform other duties as needed and as directed by your line of supervision. Minimum Education:
Bachelor's Degree in Engineering or related field required. Minimum
Experience:
5-7 years' experience in medical device or regulated manufacturing .
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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