Quality Assurance

Denttach LLC

Greenville, Northern (NC, KY)

Hybrid

USD 32,000 - 43,000

Full time

7 days ago

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Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Short-term disability

EAP program

Commuter benefits

401K plan

Job summary

Denttach LLC is seeking a Quality Assurance Specialist to support quality execution across medical device manufacturing operations on-site in Greenville, NC. The role focuses on guiding manufacturing personnel, supporting investigations, ensuring compliance, and identifying practical process improvements.

The ideal candidate has 4+ years in QA/QC or related fields, with experience in ISO 13485 environments and strong data-analysis skills.

Qualifications

Bachelor's degree in Engineering, Life Sciences, Technology, Quality, Microbiology or related field.
Minimum 4 years in Quality Assurance, Quality Control, Engineering, Operations or Manufacturing.
Experience in medical devices or highly regulated manufacturing preferred.
ISO 13485 QMS experience preferred.

Responsibilities

Perform daily quality assessments of facilities, personnel, and activities to identify issues.
Ensure compliance with site procedures, QMS, cGMPs and medical device regulations.
Maintain production-floor presence to provide quality oversight.
Assist with troubleshooting, documentation corrections, and proper controlled practices.
Guide contamination control, process controls and approved work instructions.
Lead quality event responses and support nonconformances and CAPAs.
Review and approve procedures, work instructions, and forms of moderate to high complexity.
Collaborate on root cause analyses and investigations of quality events.
Analyze batch production records for quality and traceability.

Skills

Quality Assurance

Quality Control

Regulatory compliance

Data analysis

Root cause analysis

GxP familiarity

Education

Bachelor's degree in Engineering/Life Sciences/Quality

Tools

QMS

CAPA system

Job description

Quality Assurance Specialist

Location: Greenville, NC
Pay Rate: $27.00 per hour
Schedule: 6:00 PM - 6:00 AM | 12-hour shifts | 2-2-3 rotation
Work Setting: Fully On-Site
Interview: In-Person
Employment Type: Full-Time

Position Summary

We are seeking an experienced Quality Assurance Specialist to support quality execution across medical device manufacturing operations, including manufacturing, assembly, inspection, testing, packaging, and related production activities.

This position will serve as a quality resource on the production floor, providing guidance to manufacturing personnel, supporting quality investigations, ensuring compliance with established procedures and regulatory requirements, and identifying opportunities for practical process and continuous improvement.

The ideal candidate will have experience in Quality Assurance, Quality Control, engineering, operations, or manufacturing, preferably within a highly regulated environment such as medical devices, pharmaceuticals, or other regulated manufacturing industries.

Key Responsibilities

Perform daily quality assessments of facilities, personnel, manufacturing activities, and documentation to identify errors, deficiencies, and potential compliance concerns.
Ensure manufacturing activities comply with site procedures, the Quality Management System (QMS), cGMPs, and applicable medical device regulatory requirements.
Maintain a consistent presence on the production floor to provide quality oversight and support.
Work directly with employees to assist with troubleshooting, documentation corrections, and proper adherence to controlled manufacturing practices.
Provide guidance on contamination control, process controls, and approved work instructions.
Champion a strong quality culture by helping employees understand and apply QMS procedures, quality policies, process controls, and applicable regulatory requirements.
Participate in quality event response activities and provide quality guidance during nonconformances, deviations, and other manufacturing quality events.
Escalate nonconformance and deviation events to appropriate functional and Quality management teams.
Review and approve procedures, work instructions, training documents, specifications, and forms of moderate to high complexity.
Review and approve nonconformance, deviations, CAPAs, and change controls of moderate to high complexity.
Participate as a Quality Assurance representative in root cause analysis and investigations involving nonconformances, deviations, complaints, and other quality events.
Perform quality review of batch production records and associated documentation.
Capture and analyze quality data to identify trends, issues, and opportunities for improvement.
Partner with production and technical leadership to troubleshoot process, inspection, testing, documentation, and equipment issues.
Identify continuous improvement opportunities and participate in practical process and quality-system improvement initiatives.
Promote accountability, ownership, and adherence to quality standards throughout manufacturing operations.

Qualifications

Bachelor's degree, preferably in Engineering, Life Sciences, Technology, Quality, Microbiology, or a related technical field.
Equivalent combinations of education, training, and relevant work experience may be considered.
Minimum of 4 years of relevant experience in Quality Assurance, Quality Control, Engineering, Operations, or Manufacturing.
Previous experience in the medical device industry or another highly regulated manufacturing environment is strongly preferred.
Experience working within an ISO 13485-compliant Quality Management System (QMS) is preferred.
Familiarity with applicable medical device regulatory requirements is preferred.
Experience in other regulated manufacturing environments may be considered.
Strong ability to capture, analyze, and interpret data.
Strong troubleshooting and problem-solving skills.
Ability to identify and resolve process, inspection, testing, documentation, and equipment issues.
Strong written and verbal communication skills.
Demonstrated ownership, accountability, and attention to detail.
Ability to lead, support, coach, and empower peers and production personnel.
Ability to work effectively both independently and as part of a cross-functional team.
Professional certifications such as Certified Quality Auditor (CQA) and training in Six Sigma are a plus.

Schedule

6:00 PM - 6:00 AM
12-hour shifts
2-2-3 rotating schedule
40-minute paid lunch
Schedule may include weekends and holidays based on business and production needs.
Training may be provided on an alternate schedule as needed.

Physical Requirements

This position requires consistent production-floor presence and the ability to:

Stand and walk for extended periods.
Periodically stoop, kneel, crouch, bend, and reach.
Lift, carry, and move materials weighing approximately 10-35 pounds.
Perform repetitive arm, hand, and finger movements.
Grasp and type for prolonged periods.
Use computers, monitors, production equipment, and other systems.
Read documentation and other materials for extended periods.
Communicate effectively with team members and production personnel.
Perform required gowning and follow controlled manufacturing-area procedures.
Maintain the physical ability necessary to safely perform assigned duties.

Required PPE

Employees may be required to wear:

Safety glasses
Safety shoes
Lab coat
Nitrile or similar protective gloves
Safety apron
Organic respirator when required

Work Environment

This is a fully on-site position in a regulated manufacturing environment. The Quality Assurance Specialist will maintain a consistent presence on the production floor and work closely with manufacturing, technical, and Quality teams.

The successful candidate must be comfortable working in a fast-paced manufacturing environment while following established quality, safety, documentation, and regulatory requirements.

Interview Process

In-person interview

Compensation

$27.00 per hour

Pay Details: $27.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.