Senior QA Engineer - Medical Devices & Compliance

Merit Medical Systems, Inc.; Pearland (TX); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Multiple shifts

Medical insurance

Onsite clinic

Onsite cafeterias

Employee garden

Vacation & holidays

401K & HSA

Job summary

Merit Medical Systems, Inc. is seeking a Quality Engineer to evaluate and apply standard engineering techniques within a regulated medical devices environment. You will drive risk management, ECNs, supplier audits, and CAPA activities to ensure compliance and product quality.

The role requires collaboration across teams, strong problem-solving, and knowledge of 21 CFR 820, ISO 13485, and quality tools. A Bachelor's in Engineering with several years of experience is preferred.

Qualifications

• Bachelor's degree in Engineering or related field with three years quality engineering experience.
• Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member.
• Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device standards.
• Proven ability to work effectively in a team environment through conflict resolution and negotiations.
• Working knowledge of statistical methodologies, quality control and manufacturing tools, such as applied statistics, lean manufacturing, Six Sigma, etc.
• Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.

Responsibilities

• Evaluate, select and apply standard engineering techniques on assigned projects.
• Work independently on standard projects with guidance for unusual problems.
• Participate in risk management documentation and CAPA activities; facilitate changes.
• Review, approve and generate ECNs for verification, validation and production control methods.
• Evaluate supplier performance and perform supplier quality audits.
• Review nonconformance records to determine disposition and root cause.
• Ensure containment of nonconforming product to prevent use.
• Improve quality management system using data, audits and quality policy.
• Evaluate work environment to ensure suitable environmental controls for manufacturing.
• May participate in design and development activities.
• Perform other related duties as required.

Skills

Quality engineering

FDA 21 CFR 820

ISO 13485

Statistical methods

Lean manufacturing

Six Sigma

Team collaboration

Education

Bachelors in Engineering

Tools

SmartCAPA

Oracle

Crystal Reports

Job description

Merit Medical Systems, Inc. is seeking a Quality Engineer to evaluate and apply standard engineering techniques within a regulated medical devices environment. You will drive risk management, ECNs, supplier audits, and CAPA activities to ensure compliance and product quality.

The role requires collaboration across teams, strong problem-solving, and knowledge of 21 CFR 820, ISO 13485, and quality tools. A Bachelor's in Engineering with several years of experience is preferred.