CAPA & Internal Audit Engineer II

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.

WORK SHIFT

DAY (United States of America)

SUMMARY OF DUTIES

Provides routine and complex quality systems work for CAPAs and Internal Audits. Responsibilities include: CAPA records activities throughout the lifecycle of the CAPA performing data collection and trending for presentation of key metrics, identifying and addressing quality issues via internal audit process, and optimizing and improving quality systems and documentation.

ESSENTIAL FUNCTIONS PERFORMED

1. Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.

2. Evaluates and ensures the timely completion of CAPA system activities throughout the lifecycle of the CAPA.

3. Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.

4. Supports the attainment of CAPA goals and objectives, prepares metrics for Management Review

5. Coordinates CAPA Board Management reviews 6. Conduct internal audits and facilitate the Internal audit program.

7. Lead and Perform on-site quality management system (QMS) internal audits to ensure compliance with internal and regulatory requirements.

8. Preparation and Support of third party audits (Supplier, FDA, EU Notified bodies) in the front and, back room.

9. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. 10. Works independently on standard projects while assistance is furnished on unusual problems.

11. Receives instructions on specific assignment objectives, complex features and possible solutions.

12. 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).

13. Reviews nonconformance records (internal/external) to determine disposition, root cause and need for corrective and preventive actions.

14. Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.

15. 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.

16. 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 Master Control, Oracle and DOMO.

• Experience handling Internal Audits Issues and CAPAs.

· Certified Internal Auditor or Lead Auditor for ISO13485

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.