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. Key Accountabilities and Responsibilities Adheres to GB Core Beliefs and all safety and quality requirements including, but not limited to, Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements. Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained. Leads and implements various product and process improvement methodologies. Reviews the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc. Leads in the completion and maintenance of risk analysis. Leads generation and completion of protocols and reports for test method validations. Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies, recommending process monitoring devices where applicable. Develops various inspection techniques and procedures to ensure product integrity to design specifications, and is responsible for the writing, approval and implementation of Incoming, In‑Process and Final Inspection procedures. Ensures that the disposition of non‑conforming materials meets all necessary regulatory requirements and ensures adequate corrective actions to prevent re‑occurrence. Effectively communicates and interacts with customers. Leads and manages complaint investigations. Acts 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. Assists with product transfers. Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems, leading each group with capability studies and the application of statistical quality control including Cpk, DOE, Hypothesis Testing, etc. Provides support to other quality engineers. Performs other functions as required. Minimum Education Bachelor's Degree in Engineering or related field required. Minimum Experience 5–7 years' experience in medical device or regulated manufacturing. Specialized Knowledge and Skills Competence in the selection and use of Quality Engineering Tools and Techniques. Good knowledge of relevant Domestic and International Regulations and Industry Standards (e.g., ISO, QSR, UL, MDD, TGA). Proficient in Microsoft Office and Minitab. Ability to work independently and in a team environment. Ability to 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 certifications desired: 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. Salary Range $93,225 – $136,730 Benefits Our total rewards program includes a base salary and a cash‑based incentive program, immediate eligibility for medical, dental, vision, disability, life insurance, adoption benefits, and parental leave after one year. Optional employee‑paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 10 days of company‑designated holidays per year plus an annual allotment of paid time off. Equal Opportunity Employer U.S. Applicants: Equal Opportunity Employer. Veterans and individuals with disabilities are encouraged to apply. #J-18808-Ljbffr