ESSENTIAL FUNCTIONS PERFORMED

Conducts complete and conceptually related studies to approach technical problems, whereas the problems are difficult to define, require unconventional or novel approaches, and require sophisticated research techniques.

Performs technical work where available guides and precedents contain critical gaps, are only partially related to the problem, or may be largely lacking due to the novel character of the project.

Contributes techniques which are of material significance to solve specific problems and drive continuous improvement.

Keeps abreast of new scientific methods, standards, regulations, and developments affecting the organization for the purpose of recommending changes to processes, systems or designs warranted by such developments.

May plan, organize, mentor, and supervise the work of engineers or technicians on various engineering projects and quality system compliance issues.

Responsible for coordinating risk analysis/management activities. This may include leading risk management analysis meetings, documenting results, following up to ensure risk mitigation and facilitating improvements.

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).

Mentors and evaluates competency of Quality Auditors, Quality Engineers, and technicians, by providing training or other actions required to satisfy quality objectives.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

Lifting -- Not to exceed 50 lbs. – local practice may apply.

Writing

Sitting

Standing

Bending

VisionColor perception

Depth perception

Reading





Field of vision/peripheral

Fine motor skills

Noise

Chemical vapors

MINIMUM QUALIFICATIONS

Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field with six years of quality engineering experience (to include experience in the development and implementation of effective quality systems).

Advanced English level

Prior medical indsutry 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.

Knowledge of applicable regulatory agency regulations.

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 deviations, investigations and CAPAs.

Experience with MasterControl, SmartCAPA, Oracle and Crystal.

COMPETENCIES

Engineering problem solving/decision making

Technician supervision

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.

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📌 Sr Quality Assurance Engineer I (temporary 4 months) (Centro-Norte)
🏢 Merit Medical
📍 Centro-Norte