Quality Assurance - Quality Engineer I

Viant•Fort Wayne, IN

About The Position

The Quality Engineer I provides Quality Engineering support for Operations to ensure that Quality System requirements are followed in medical device manufacturing and operations in accordance with applicable regulatory and standards requirements. This is an independent-contributor role. The position supports product and process quality, regulatory compliance, inspections and audits, improvement activities, and resolution of quality issues across manufacturing and suppliers.

Requirements

Bachelor’s degree in Engineering or a related field, or 2–5 years of experience working in a quality engineering role within a regulated industry.
0–2 years of experience in medical device or regulated manufacturing.
Ability to multitask and drive initiatives to completion.
Competence in selecting and using Quality Engineering tools and techniques.
Strong communication skills and ability to align with key stakeholders.
Working knowledge of interpreting and applying relevant domestic and international regulations and industry standards, such as FDA 21 CFR 820, ISO 13485:2016, MDSAP, ISO 14971, QSR, MDD, and TGA.
Proficiency in Microsoft Office and Minitab.
Ability to perform light work: exert up to 20 pounds of force occasionally and/or up to 10 pounds frequently, and lift, carry, push, pull, or move objects.
Close vision.

Responsibilities

Adhere to Viant Core Beliefs and safety and quality requirements, including QMS, EMS, FDA regulations, company policies and procedures, and other regulatory requirements.
Support regulatory and agency inspections, audits, investigations, and inquiries related to product design and manufacturing quality.
Monitor manufacturing of assigned products for compliance with DMRs, provide deviation and waiver guidance, and ensure Device History Records are complete and correct.
Implement product and process improvement methodologies.
Review changes to Bills of Materials, assembly procedures, drawings, component specifications, FMEAs, control plans, and related documents for adequacy and correctness.
Maintain risk analyses.
Complete protocols and reports for test method validation.
Work with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies; recommend process monitoring devices where applicable.
Develop inspection techniques and procedures to ensure product integrity to design specifications, and write, approve, and implement incoming, in-process, and final inspection procedures.
Ensure nonconforming-material dispositions meet regulatory requirements and corrective actions are adequate to prevent recurrence.
Communicate and interact effectively with customers.
Complete complaint investigations.
Execute plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes.
Assist with product transfers.
Work with suppliers, management, engineers, and manufacturing associates to resolve quality problems; execute capability studies and apply statistical quality control methods, including Cpk, DOE, and hypothesis testing.
Coordinate preparation of Quality Plans, including inspection, test, and gauge requirements for new product introductions.
Provide support to other quality engineers and perform other functions as required.
Manage a heavy workload while maintaining accuracy, identify potential roadblocks and provide innovative solutions, operate with integrity and professionalism, and remain accountable for achieving goals and objectives.