Integer
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. We create better solutions. We create success together. Inclusion
We always interact with others respectfully. We are open and honest with one another. Integrity
We do the right things and do things right. The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Provide work direction for 3-5 Technicians/Inspectors. Key Accountabilities and Responsibilities:
Adhere to Integer’s Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), Company policies and operating procedures, and other regulatory requirements. Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained. Lead and implement various product and process improvement methodologies. Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc. Lead in the completion and maintenance of risk analysis. Lead generation and completion of protocols and reports for test method validations. Interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommend process monitoring devices where applicable. Develop various inspection techniques and procedures to ensure product integrity to design specifications. Be responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures. Ensure that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence. Effectively communicate and interact with customers. Lead and manage complaint investigations. Act as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis. Assist with product transfers. Work with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Lead each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc. Provide support to other quality engineers. Perform other functions as required. 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, UL, 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 About the company
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.
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We focus on our customers’ success. We create better solutions. We create success together. Inclusion
We always interact with others respectfully. We are open and honest with one another. Integrity
We do the right things and do things right. The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Provide work direction for 3-5 Technicians/Inspectors. Key Accountabilities and Responsibilities:
Adhere to Integer’s Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), Company policies and operating procedures, and other regulatory requirements. Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained. Lead and implement various product and process improvement methodologies. Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc. Lead in the completion and maintenance of risk analysis. Lead generation and completion of protocols and reports for test method validations. Interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommend process monitoring devices where applicable. Develop various inspection techniques and procedures to ensure product integrity to design specifications. Be responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures. Ensure that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence. Effectively communicate and interact with customers. Lead and manage complaint investigations. Act as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis. Assist with product transfers. Work with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Lead each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc. Provide support to other quality engineers. Perform other functions as required. 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, UL, 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 About the company
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.
#J-18808-Ljbffr