Quality Engineer – Medical Device Industry
Location: Kennesaw, GA | On-site
Salary: $70,000–$75,000
Employment Type: Full-Time
Schedule: Monday–Friday, 8:00 AM–5:00 PM
Openwork is sourcing on behalf of our client, a growing organization in the
medical device industry. We are seeking a Quality Engineer to join their
Regulatory Affairs & Quality Assurance team and support quality activities
across the product life cycle.
About the Role
The Quality Engineer will support quality engineering activities from new
product development and commercialization through sustaining changes. This role
works closely with cross-functional teams on product quality, process
development, validation, risk management, regulatory compliance, and continuous
improvement.
Key Responsibilities
* Support the transfer of new products into production, including process
validation activities such as PFMEA, IQ, OQ, and PQ.
* Assist with verification and validation test plans, protocols, and reports.
* Support compliance with applicable FDA and regulatory requirements.
* Review product designs for manufacturability, reliability, testability, and
quality requirements.
* Participate in product risk management activities, including risk
assessments, dFMEA, and risk management reports.
* Support supplier quality, manufacturing quality, and customer complaint
investigations.
* Apply statistical tools and techniques to quality and process improvement
initiatives.
* Manage multiple projects, timelines, and deliverables while working with
cross-functional teams.
* Develop technical protocols, reports, procedures, and other quality
documentation.
* Participate in root cause investigations and corrective/improvement
activities.

Preferred Qualifications
* 1–2+ years of experience in the medical device, life sciences, or related
regulated industry.
* Bachelor’s degree in Engineering, Life Sciences, or a related field. An
Associate’s degree in Engineering Technology or a related technical
discipline may be considered with relevant experience.
* Experience with ISO 14971 risk management.
* Knowledge of FDA Quality System Regulation, ISO 13485, and medical device
regulatory requirements.
* Experience with IQ/OQ/PQ process validation.
* Familiarity with DOE, SPC, capability analysis, GR&R, sampling plans,
hypothesis testing, ANOVA, and other statistical methods.
* Experience with statistical software such as Minitab or similar tools.
* Knowledge of verification/validation, root cause analysis, and failure
investigation.
* Exposure to stability, biocompatibility, sterilization, or shipping/transport
testing is a plus.
* Familiarity with Lean and Six Sigma methodologies is preferred.
* Strong technical writing, communication, organization, and problem-solving
skills.

The Process: If you are interested and qualified for this position, please APPLY
NOW. If you have questions regarding the qualifications, please contact Jessika
at JESSIKA.BRIGGS@OPENWORK.COM
#OPWTXDH