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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 primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the QualitySystem requirements are adhered to for medical device manufacturing/operations in accordance with applicableRegulatory and Standards requirements for compliance. Key Accountabilities and Responsibilities
Adheres to Integer values and all safety and quality requirements including, but not limited to: QualityManagement Systems (QMS), Environmental Management Systems (EMS), U.S. Food and DrugAdministration (FDA) regulations, Company policies and operating procedures, and other regulatoryrequirements. Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control andassessment of product design and manufacturing quality. Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiverguidance and assuring complete and correct Device History Records are maintained. Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures,Drawings, Component Specification, FMEAs, Control Plans, etc. Lead generation and completion of protocols and reports for test method validations. Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinateprocess validations and capability studies. Recommends process monitoring devices where applicable. Develops 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 Inspectionprocedures. Ensure that the disposition of non-conforming materials meet all necessary regulatory requirements and assureadequacy of corrective actions to prevent re-occurrence. Lead and manage complaint investigations. Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality,nonconforming material, training effectiveness, and root causes analysis. Participate in continuous improvement projects. Assist with product transfers. Works with suppliers, management, Engineers and Manufacturing associates in the resolution of qualityproblems. Also, assists each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc. Mentor and support quality inspectors and technicians. Performs other functions as required.
Job Requirements
Minimum Education: Bachelor's Degree in Engineering or related field required. Minimum Experience: 2-5 years quality engineering experience, preferably in medical device or regulatedmanufacturing
Specialized Knowledge:
Competence in the selection and use of Quality Engineering Tools and Techniques. Good knowledge in the interpretation and application of relevant Domestic andInternational Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) Proficient in Microsoft Office and Minitab 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. 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.
Salary Range for this position is $77,550 - $113,740 U.S. Applicants: EOE/AA Disability/Veteran
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Integer Holdings
Jan 23, 2025