Quality Engineer III

Company Values 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. Role Overview The primary purpose of this position is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable regulatory and standards requirements for compliance. The role will provide work direction for 3‑5 Technicians/Inspectors. 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 ensuring 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 (BOMs), Assembly Procedures, Drawings, Component Specifications, 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; recommends process monitoring devices where applicable. Develops various inspection techniques and procedures to ensure product integrity to design specifications; responsible for writing, approving and implementing Incoming, In‑Process and Final Inspection procedures. Ensures that the disposition of non‑conforming materials meets all necessary regulatory requirements and assures adequacy of 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; also leads each of these groups with capability studies and the application of statistical quality control which include 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 of experience in medical device or regulated manufacturing. Specialized Knowledge Competence in the selection and use of Quality Engineering Tools and Techniques; good knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g., ISO, QSR, UL, MDD, TGA, etc.); proficiency in Microsoft Office and Minitab. Special Skills Ability to work independently and in a 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. Certifications Desired certifications: Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA); Six Sigma Green Belt or Black Belt. Salary Range $93,225 - $136,730 Benefits Base salary and a cash-based incentive program; comprehensive benefits package including medical, dental, vision, disability, life insurance and adoption benefits; parental leave after one year; optional employee‑paid supplemental insurance; eligibility to participate in 401(k) plan with company matching; 80 hours of company designated holidays per year plus annual paid time off. Equal Opportunity Employer Integer Holdings Corporation is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, or any other protected characteristics. Veterans and individuals with disabilities are encouraged to apply. We celebrate many differences and remain committed to an inclusive workplace free from harassment and discrimination. #J-18808-Ljbffr Integer Holdings Corporation