Senior QA Engineer II - Medical Devices, Flexible Shifts

Regulatory Jobs; Pearland (TX); On-site; USD 95,000 - 140,000; Full time

Benefits offered by this job

Medical/Dental & Other Insurances

Onsite Medical Clinic

Onsite Cafeterias

Vacation and Sick Time

401K / Health Savings Account

Job summary

Merit Medical is seeking a Senior Quality Engineer to lead risk management, supplier QA, and ECN activities for our medical device products. You will evaluate processes, drive corrective actions, and help maintain compliance with 21 CFR 820 and ISO standards.

The role requires a Bachelor's in Engineering with 10 years in quality engineering in regulated environments; experience with MasterControl eQMS, ISO 13485, and Six Sigma is preferred.

Qualifications

• Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field with ten years quality engineering experience.
• Medical device experience or equivalent experience in a regulated industry.
• 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, ISO 13485, ISO 14791, and other medical device related 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.

Responsibilities

• Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria; makes minor adaptations.
• Works independently on standard projects with assistance on unusual problems.
• Responsible for risk management documentation for assigned product lines and processes; facilitates teams and implements changes.
• Reviews, approves and generates ECNs to update verification, validation, monitoring and inspection methods and test protocols.
• Evaluates supplier performance and conducts supplier quality audits.
• Reviews nonconformance records to determine disposition, root cause and CAPA needs.
• Ensures containment of nonconforming product to prevent unintended use.
• Identifies and implements changes to ensure the quality management system remains effective.

Skills

Interpersonal skills

Organizational skills

Verbal communication

Written communication

Teamwork

Education

Bachelor's degree in Engineering or related field

Ten years quality engineering experience

Medical device experience or regulated industry

Tools

MasterControl eQMS

Oracle

Power BI

Extrusion process

Process Validation

TMV

Job description

Merit Medical is seeking a Senior Quality Engineer to lead risk management, supplier QA, and ECN activities for our medical device products. You will evaluate processes, drive corrective actions, and help maintain compliance with 21 CFR 820 and ISO standards.

The role requires a Bachelor's in Engineering with 10 years in quality engineering in regulated environments; experience with MasterControl eQMS, ISO 13485, and Six Sigma is preferred.