Quality Assurance Engineer II (Molding)

Merit Medical; Tijuana; On-site; MXN 524,475 - 874,126; Full time

Job summary

Merit Medical in Tijuana seeks a Quality Engineer to manage risk documentation and ensure quality control in medical device production. Candidates should hold a Bachelor's Degree in Engineering and have at least three years of experience in the medical field.

The role requires strong interpersonal skills, knowledge of quality standards, and proficiency with statistical methodologies. Applicants must demonstrate the ability to work effectively in a team.

Qualifications

• 3 years of quality engineering experience in medical devices.
• Advanced English level required.
• Demonstrated knowledge of 21 CFR 820 and ISO standards.

Responsibilities

• Evaluate engineering techniques and make adaptations.
• Manage risk documentation for product lines.
• Review Engineering Change Notifications (ECNs).

Skills

Quality engineering in medical devices

Statistical methodologies

Lean manufacturing

Six Sigma

Interpersonal communication

Education

Bachelor's Degree in Engineering or related field

Tools

MS Excel

Database software

Job description

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.

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.
• Prior medical industry experience
• Advanced English level
• 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. Risk category II states employment and procedures that may require exposure.