## Quality Assurance Engineer II (Molding)Applyremote type:
Onsitelocations:
Tijuana, Mexicotime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
JR **Work Shift:**DAY**Work Schedule:****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: mold verification, mold validation, monitoring and inspection methods, procedures, and test protocols; specific to mold product line(s) and processes and production control(s).
6.
Reviews nonconformance records (internal/external) to determine: disposition, root cause and
need for corrective and preventive actions.
7.




Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
8.
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.
9.
Evaluates the work environment, in which product is manufactured, is adequately
environmentally
controlled and monitored, with sufficient personnel and safety production
controls.
10.
May participate in design and development of mold activities.
11.
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 in medical devices.
•
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 handling non-conformances, deviations, investigations and CAPAs.•
Experience in revieweing and approving validations for molded products.
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.

📌 Quality assurance engineer ii (molding) (Centro-Norte)
🏢 Merit Medical Systems
📍 Centro-Norte