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.
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