Medical Device Quality Engineer — Process Validation & Compliance

Openwork, formerly Meador Staffing Services; Kennesaw (GA); On-site; USD 70,000 - 100,000; Full time

Job summary

Openwork is seeking a Quality Engineer for a medical device client in Georgia. The role supports quality activities across the product lifecycle, partnering with cross-functional teams on development, validation, risk management and regulatory compliance.

The engineer will contribute to transfer to production, validation planning, and quality documentation while applying SPC/DOE tools and root-cause analysis to drive continuous improvement.

Qualifications

• 1–2+ years in medical device or related regulated industry.
• Bachelor's degree in Engineering, Life Sciences, or related field; associate degree with relevant experience considered.
• Experience with ISO 14971 risk management.
• Knowledge of FDA Quality System Regulation and ISO 13485.
• Experience with IQ/OQ/PQ process validation.
• Familiar with DOE, SPC, GR&R, sampling plans and hypothesis testing.
• Proficient in statistical methods and tools such as Minitab.
• Experience with verification/validation, root cause analysis and failure investigations.
• Exposure to stability, biocompatibility, sterilization, or shipping testing is a plus.
• Lean and Six Sigma familiarity is preferred.
• Strong technical writing, communication and problem-solving skills.

Responsibilities

• Support transfer of new products into production including process validation (PFMEA, IQ, OQ, PQ).
• Assist with verification and validation test plans, protocols and reports.
• Support FDA and regulatory compliance.
• Review designs for manufacturability, reliability and quality.
• Participate in risk management activities and risk reports.
• Support supplier, manufacturing and customer complaint investigations.
• Apply statistical tools for quality and process improvements.
• Manage multiple projects with cross-functional teams.
• Develop protocols, reports and quality documentation.
• Participate in root cause investigations and corrective actions.

Skills

Quality engineering

Risk management

Process validation

DOE

SPC

GR&R

Hypothesis testing

ANOVA

Verification/validation

Root cause analysis

Regulatory knowledge

Technical writing

Cross-functional teamwork

Education

Bachelor's degree in Engineering/Life Sciences

Associate degree in Engineering Technology (considered with experience)

Tools

Minitab

Job description

Openwork is seeking a Quality Engineer for a medical device client in Georgia. The role supports quality activities across the product lifecycle, partnering with cross-functional teams on development, validation, risk management and regulatory compliance.

The engineer will contribute to transfer to production, validation planning, and quality documentation while applying SPC/DOE tools and root-cause analysis to drive continuous improvement.