Quality Assurance - Quality Engineer I

Viant Medical Inc.; Fort Wayne (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

Viant Medical Inc. is seeking a Quality Engineer to support Operations in maintaining compliance with QMS, EMS, FDA regulations, and industry standards.

The role involves coordinating QA activities, CAPA, audits, and process improvements across manufacturing processes. The ideal candidate has a engineering background with hands-on experience in regulated manufacturing, strong communication, and proficiency with quality tools such as Minitab and MS Office.

Qualifications

• Bachelor's Degree in Engineering or related field; 2-5 years in a quality engineering role within a regulated industry.
• 0-2 years' experience in medical device or regulated manufacturing.

Responsibilities

• Adheres to Quality Management Systems (QMS), EMS, FDA regulations, and company policies.
• Supports regulatory inspections, audits, investigations, and inquiries on product design and manufacturing quality.
• Monitors manufacturing for compliance with DMR; provides deviation/waiver guidance and maintains Device History Records.
• Implements product and process improvement methodologies.
• Reviews changes to BOMs, assembly procedures, drawings, component specs, FMEAs, and control plans.
• Maintains risk analyses and completes test protocol/validation reports.
• Coordinates process validations and capability studies; advises on monitoring devices where applicable.
• Develops inspection techniques and procedures for Incoming, In-Process, and Final Inspection.
• Ensures disposition of non-conforming materials meets regulatory requirements and drives corrective actions.
• Communicates with customers; completes complaint investigations.
• Executes CAPA activities; analyzes data and trends in complaints, supplier quality, and root causes.
• Assists with product transfers; collaborates with suppliers and engineers to resolve quality problems.

Skills

Multitasking

Quality tools & techniques

Communication

Regulatory knowledge

MS Office

Education

Bachelor's degree in Engineering

Tools

Minitab

MS Office

Job description

Description: 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. Independent contributor.

Responsibilities

• Adheres to Viant 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.
• Implements 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.
• Maintains risk analyses.
• Completes protocols and reports for test method validation.
• 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 the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
• Ensures 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.
• Completes complaint investigations.
• Executes 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, executes capability studies and the applies statistical quality control which includes Cpk, DOE, Hypotheses Testing, etc.
• Coordinates the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductions
• Provides support to other quality engineers.
• Performs other functions as required.
• Manage a heavy workload while maintaining accuracy
• Identify potential roadblocks and provide innovative solutions
• Operate with a high level of integrity and professionalism
• 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

• 0-2 years' experience in medical device or regulated manufacturing

Skills/Competencies

• Ability to multitask and drive initiatives to completion
• 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

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.
• Visual Acuity: Close vision.
• Travel: Less than 10%
• Equipment Used: N/A
• Work Conditions: Worker is not exposed to adverse environmental conditions