Quality Engineer

Quality Engineering Support New employees are eligible for the following benefits effective date of hire! Full Medical, Dental & Vision, 401(k), generous paid time off benefits and 10 paid Holidays, growth opportunities, on-demand pay, and market competitive compensation. Potential salary range for this role is $70,000-95,000 annual wage. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 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 medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Responsibilities include: Adhering to Viant Core Beliefs and all safety and quality requirements including Quality Management Systems, Environmental Management Systems, FDA regulations, Company policies and operating procedures, and other regulatory requirements. Supporting regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. Monitoring manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained. Leading and implementing various product and process improvement methodologies. Reviewing the adequacy and correctness of changes to Bill of Materials, Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc. Leading in the completion and maintenance of risk analysis. Generating and completing protocols and reports for test method validations. Interfacing with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommending process monitoring devices where applicable. Developing 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. Ensuring that the disposition of non-conforming materials meet all necessary regulatory requirements and assuring adequacy of corrective actions to prevent re-occurrence. Effectively communicating and interacting with customers. Leading and managing complaint investigations. Acting 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. Assisting with product transfers. Working with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, leading each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc. Coordinating and leading the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductions. This position may provide work direction for 3-5 Inspectors/Technicians. Providing support to other quality engineers. Performing other functions as required. The successful candidate will: Manage a heavy workload while maintaining accuracy. Identify potential roadblocks and provide innovative solutions. Operate with a high level of integrity and professionalism. Be committed to and accountable for achieving goals and objectives. Education/Certification: Bachelor's Degree in Engineering or related field required or 2 – 5 years of experience working in a quality engineering role within a regulated industry. Experience: 2-5 years' experience in medical device or regulated manufacturing. Skills/Competencies: Competence in the selection and use of Quality Engineering Tools and Techniques. Strong communication skills and ability to align with key stakeholders. Strong working knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. FDA 21CRF820, ISO 13485:2016; MDSAP; ISO14971, QSR, MDD, TGA etc.) Proficient in Microsoft Office and Minitab. Travel: Less than 10% Physical Requirements: Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects.