Quality EngineercGxPServe Inc. • Magna, UT, US
Quality Engineer
cGxPServe Inc. • Magna, UT, US
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job_description.job_card.job_descriptionBachelor's degree in engineering, Life Sciences, or related field. 2+ years of quality engineering experience in the medical device or regulated industry. Strong knowledge of FDA QSR (21 CFR Part 820) and ISO 13485. Experience with risk management (ISO 14971) and design control practices. Hands-on experience with CAPA, validation (IQ / OQ / PQ), and audits. Proficient in quality tools such as FMEA, 8D, Root Cause Analysis, etc. Excellent analytical, documentation, and communication skills.
Job Description
We are seeking a Quality Engineer with experience in the medical device industry to support quality assurance, regulatory compliance, and continuous improvement initiatives. The ideal candidate will have a strong background in FDA regulations, ISO 13485, risk management (ISO 14971), and product lifecycle management, including design control and CAPA systems.
Responsibilities
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory standards.
- Support design control activities including design verification / validation, risk analysis (FMEA, FTA), and product release.
- Develop and maintain quality documentation, including SOPs, work instructions, inspection plans, and validation protocols.
- Perform root cause investigations and drive Corrective and Preventive Actions (CAPA) to resolution.
- Conduct or support internal audits, supplier audits, and regulatory inspections.
- Monitor and improve product quality metrics (yield, complaints, non-conformances, etc.).
- Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory, Supply Chain) to ensure quality is built into processes and products.
- Lead or assist in supplier quality management activities, including qualifications, audits, and performance monitoring.
- Participate in risk management processes and ensure appropriate risk controls are implemented.
- Support change control processes for product or process changes.
- Contribute to continuous improvement initiatives using tools such as Six Sigma, Lean, and 8D.
Requirements
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Salt Lake City, UT
J-18808-Ljbffr
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Quality Engineer • Magna, UT, US