Senior Quality Assurance Engineer II

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

Work Shift:

DAY

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

ESSENTIAL FUNCTIONS PERFORMED

• 1. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.
• 2. Works independently on standard projects while assistance is furnished on unusual problems.
• 3. Receives instructions on specific assignment objectives, complex features and possible solutions.
• 4. Responsible for risk management documentation for assigned product line(s) or processes; and identifying and updating failure modes and related process/product improvements by facilitating teams and implementing required changes.
• 5. Reviews, approves and generates Engineering Change Notifications (ECNs) to update or generate: verification, validation, monitoring and inspection methods, procedures, and test protocols; specific to assigned product line(s) and processes and production control(s).
• 6. Evaluates and participates in the selection of suppliers by monitoring supplier performance, through collection and trending of data and performing supplier quality audits, as required.
• 7. Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
• 8. Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
• 9. Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of: quality policy, quality objectives, audit results, analysis of data, etc.
• 10. Evaluates the work environment, in which product is manufactured, is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.
• 11. May participate in design and development activities.
• 12. Performs other related duties and tasks as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

• * Lifting -- Not to exceed 50 lbs. - local practice may apply.
• * Writing
• * Sitting
• * Standing
• * Bending

• * Vision
• * Color perception
• * Depth perception
• * Reading
• * Field of vision/peripheral
• * Fine motor skills
• * Noise
• * Chemical vapors

SUMMARY OF MINIMUM QUALIFICATIONS

• * Education and/or experience equivalent to a 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 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, etc.
• * Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.

PREFERRED QUALIFICATIONS

• * Medical device experience or equivalent experience in a regulated industry.
• * Experience with SmartCAPA, Oracle and Crystal Reports.
• * Experience handling deviations, investigations and CAPAs.

COMPETENCIES

• * Engineering techniques/evaluation/selection/application
• * Engineering variable analysis
• * Plans/surveys/structures/equipment
• * Supervisory assistance
• * Special projects/ECN's/prototype creation
• * NC causes/corrective actions/dispositions

COMMENTS

Infectious Control Risk Category II:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.

As an eligible Merit employee, you can expect the following:

• * Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
• * Medical/Dental & Other Insurances (eligible the first of month after 30 days)
• * Low Cost Onsite Medical Clinic
• * Two (2) Onsite Cafeterias
• * Employee Garden | Gardening Classes
• * 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
• * 401K | Health Savings Account

To see more on our culture, go to www.merit.com/careers.

Military Veterans are encouraged to Apply.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.