Quality Engineer

Viant Medical Inc.; Northern (KY); Hybrid; USD 70,000 - 95,000; Full time

Benefits offered by this job

Full Medical, Dental & Vision on day 1

401(k) on first day

Generous PTO and 10 holidays

Growth opportunities

On-Demand Pay

Job summary

Viant Medical Inc. is hiring for a Quality Engineer to ensure QMS compliance in medical device manufacturing. You will support regulatory inspections, manage quality documentation, and drive process improvements.

The role requires 2–5 years in a regulated quality engineering environment and a bachelor’s degree in engineering or related fields. Travel and cross-functional collaboration are involved.

Qualifications

• Bachelor’s Degree in Engineering or related field required.
• 2–5 years of experience in a quality engineering role within a regulated industry.
• Experience in medical device manufacturing is preferred.

Responsibilities

• Adheres to QMS, EMS, FDA regulations and company procedures.
• Supports regulatory inspections, audits, investigations, and inquiries on quality control.
• Monitors manufacturing for compliance with DMR and maintains device history records.
• Leads and implements product and process improvement methodologies.
• Reviews changes to BOMs, assembly procedures, drawings, specs and FMEAs.
• Leads risk analysis completion and maintenance.
• Generates protocols and reports for test method validations.
• Interfaces with Manufacturing Engineers for process reviews and validations.
• Develops inspection techniques and procedures; writes inspection documentation.
• Ensures non-conforming material disposition meets regulatory requirements and CAPA.
• Communicates with customers effectively.
• Leads complaint investigations.
• Leads CAPA activities with data analysis and root-cause.
• Assists with product transfers.
• Collaborates with suppliers and engineers to resolve quality problems using SPC.
• Prepares Quality Plans for new product introductions.
• May provide direction to 3–5 Inspectors/Technicians.
• Supports other quality engineers.
• Performs other duties as required.

Skills

Quality Engineering

Regulatory compliance

Statistical methods

Documentation & QA

Communication skills

Microsoft Office

Education

Bachelor's Degree in Engineering or related field

Tools

Minitab

Job description

New employees are eligible for the following benefits effective date of hire!

• Full Medical, Dental & Vision, 401(k), effective on your 1st day


• Generous paid time off benefits and 10 paid Holidays


• Growth Opportunities


• On-Demand Pay: Access your pay as soon as you have earned it!


• We offer market competitive compensation. Potential salary range for this role is $70,000-95,000 annualwage. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

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.

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.


• Leads and 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.


• 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 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.


• Leads and manage 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, Hypotheses Testing, etc.


• Coordinates and leads 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.


• Provides support to other quality engineers.


• Performs 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


• 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