Quality Assurance Engineer II

•    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.

Provides routine and complex quality engineering work for specific product lines under broad 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.    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.