Senior Quality Assurance Engineer II

Regulatory Toolkit; 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

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 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 (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

• Experience with MasterControl eQMS, Oracle, Power BI, Extrusion process, Process Validation, TMV.
• 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.