112 empleos de Calidad

Quality Assurance Engineer II (Molding)

Merit Medical

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.

Octubre 05 2026 en Tijuana

Quality Technician A | Blvd. Insurgentes

North American Production Sharing de México, S.A. de C.V.

Requirements & Technical Profile Education: Engineering Student (mid-way through the program / with fixed schedule availability) or Incomplete Engineering Degree . Associate Degree (Tecnico Superior Universitario) in manufacturing-related fields. Preferred Degree Options: Industrial Engineering, Textile Engineering, Mechanical Engineering, or Quality Management Engineering. Work Experience: 2-3 years in manufacturing plants with industrial sewing, mechanical assembly, or harness assembly processes (preferably technical textiles, automotive, or personal protective equipment) Proficiency in Measurement Tools: Digital Calipers and Micrometers (for critical hardware and metal components dimensions). Thread Counters & Magnifiers / Lupe Scopes (for stitch density, stitch pattern verification, and web inspection). Force Gauges / Push-Pull Gauges (for checking activation forces on hooks or shock absorbers). Precision Rulers and Tape Measures (for strict length specifications on lanyards and harness straps). Tensile & Destruction Testing Machines ( Highly valued / Plus – for verifying the breaking strength of webbings, threads, and stitched joints). Essential Technical Knowledge: Problem-solving tools and root cause analysis ( 8D Methodology , 5 Whys, Ishikawa Diagram). Management and administration of sampling plans (AQL Tables / ANSI/ASQ Z1.4). Development and monitoring of Control Plans and acceptance/rejection criteria. Knowledge and control of the MRB process (Material Review Board) and segregation of non-conforming material. Participation in process audits and internal audits under quality management systems ( ISO standards ). Response, documentation, and follow-up on Corrective and Preventive Actions (CAPA) . Customer complaint management and follow-up on material supplier quality issues. Basic knowledge of statistics (control charts, process capability) and Lean tools (5S, Visual Control, Poka-Yokes).

Septiembre 24 2026 en Tijuana