Quality Assurance Engineer I

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

SUMMARY OF DUTIES

Performs routine quality engineering work for specific product lines under general supervision and guidelines. Responsibilities include: failure investigation, oversight/determination of disposition of nonconforming materials, conducting and updating risk analysis documentation and processes, defining/refining quality inspection plans, performing data collection and trending for presentation of key metrics, identifying and addressing supplier quality issues, reviewing and generating validation/protocol data, and optimizing and improving quality systems and documentation.

ESSENTIAL FUNCTIONS PERFORMED

1.    Performs routine engineering work requiring the application of standard techniques, procedures,     and criteria in carrying out engineering tasks.
2.    Uses limited amounts of discretionary judgment in making decisions regarding engineering     alternatives.
3.    Performs work of some higher technical level for training purposes, and work is screened to     ensure correct application of scientific principles.
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.    Reviewing, approving and generating 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.    Evaluating and participating in the selection of suppliers by monitoring supplier performance,     through collection and trending of data and performing supplier quality audits, as required.
7.    Reviewing nonconformance records (internal/external) to determine: disposition, root cause and     need for corrective and preventive actions.
8.    Ensuring containment (identification, segregation and reconciliation) of nonconforming product     has been performed, to prevent unintended use.
9.    Identifying and implementing 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.    Evaluating 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 Bachelors Degree in Quality Engineering or related field, or a Masters Degree.

•    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 , 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

•    Standard engineering techniques/procedures/criteria

•    Special projects/ECN's

•    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

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