163 empleos de Calidad

Plant Quality Manager

Oferta confidencial

Education Bachelor’s degree in Engineering (Electrical, Electronics, Industrial, Mechanical) or Quality Management. Master’s degree, MBA, or advanced quality certifications preferred. Fluent in conversational and written English. Experience Minimum of 10 years of experience in Quality Management within automotive or high-reliability electronics manufacturing. At least 5 years of experience in a senior leadership role managing multidisciplinary quality teams across the full product lifecycle, from product design through post‑sales service. Proven experience working with Tier 1 suppliers and/or OEM customers. Skills & Competencies In-depth knowledge of automotive electronics manufacturing processes, quality systems, and industry regulations. Proven leadership skills with experience building and leading high-performing teams. Strong analytical, problem-solving, and decision-making capabilities. Expertise in structured problem-solving, root cause analysis, and corrective action management. Excellent communication and influencing skills at all organizational levels. Experience in driving change in fast-paced, high-volume manufacturing environments. Proficient in quality systems, data analysis, and quality management software tools. Certifications (Preferred) Certified Quality Engineer (CQE) Certified Quality Auditor (CQA) Six Sigma Black Belt or equivalent Working Conditions Office-based role within the manufacturing facility with frequent presence on the production floor and quality laboratories. Occasional travel to supplier locations, customer sites, and industry meetings. Reporting Relationship Reports directly to the Plant Director. Directly manages Supplier Quality, Process Quality Assurance, Customer Quality, Quality Management Systems, Component Failure Analysis, Material Analysis, and Quality Control functions.

Hace 4 horas en Tijuana

Especialista de Cumplimiento Regulatorio (ISO 13485)

Thermo Fisher Scientific (Planta Tijuana)

A positive approach and motivated by challenges Team-player mentality Dedicated with the ability to handle tasks independently Flexibility to handle shifting priorities Confidence in collaborating with colleagues at all levels Strong written communication skills, with technical writing experience being a plus Excellent critical thinking and decision-making skills A continuous improvement approach Innovative problem-solving ability Strong organizational skills with attention to detail The Regulatory Specialist will support the Laboratory Plastics Essentials business by working closely with global manufacturing sites including locations in Tijuana (MX), Monterrey (MX) and Roskilde (DE) to ensure overall product safety and regulatory compliance. TThe RA Specialist will also act as a regulatory consultant to ensure all products comply global and regional regulations and market needs (REACH/SVHC, California Proposition 65, RoHS). Ensure availability of up-to-date technical documentation and Standard Operating Procedures Work together with LPE global teams for supporting customer requests with related RA mailboxes Work with the global environmental compliance team to oversee the management of compliance information for all sourced materials, components and finished goods Support international registrations with related technical documentation Function as an RA subject matter expert on new product introductions, capacity expansion projects and custom product development and manufacturing Complete timely regulatory safety evaluations on customer complaints and manufacturing non-conformance activities for regulated products Provide regulatory input to QA in Deviations, CAPAs, Management Review and complaints Provide guidance regarding regulatory and performance test requirements for product claims and the design verification and validation of products (including sterilization, biocompatibility, labelling, clinical, and packaging validation)

Hace 4 horas en Tijuana

Especialista de Cumplimiento Regulatorio (ISO 13485)

Thermo Fisher Scientific (Planta Tijuana)

A positive approach and motivated by challenges Team-player mentality Dedicated with the ability to handle tasks independently Flexibility to handle shifting priorities Confidence in collaborating with colleagues at all levels Strong written communication skills, with technical writing experience being a plus Excellent critical thinking and decision-making skills A continuous improvement approach Innovative problem-solving ability Strong organizational skills with attention to detail The Regulatory Specialist will support the Laboratory Plastics Essentials business by working closely with global manufacturing sites including locations in Tijuana (MX), Monterrey (MX) and Roskilde (DE) to ensure overall product safety and regulatory compliance. TThe RA Specialist will also act as a regulatory consultant to ensure all products comply global and regional regulations and market needs (REACH/SVHC, California Proposition 65, RoHS). Ensure availability of up-to-date technical documentation and Standard Operating Procedures Work together with LPE global teams for supporting customer requests with related RA mailboxes Work with the global environmental compliance team to oversee the management of compliance information for all sourced materials, components and finished goods Support international registrations with related technical documentation Function as an RA subject matter expert on new product introductions, capacity expansion projects and custom product development and manufacturing Complete timely regulatory safety evaluations on customer complaints and manufacturing non-conformance activities for regulated products Provide regulatory input to QA in Deviations, CAPAs, Management Review and complaints Provide guidance regarding regulatory and performance test requirements for product claims and the design verification and validation of products (including sterilization, biocompatibility, labelling, clinical, and packaging validation)

Hace 4 horas en Monterrey

Especialista de Cumplimiento Regulatorio (ISO 13485) - Foránea

Thermo Fisher Scientific (Planta Tijuana)

A positive approach and motivated by challenges Team-player mentality Dedicated with the ability to handle tasks independently Flexibility to handle shifting priorities Confidence in collaborating with colleagues at all levels Strong written communication skills, with technical writing experience being a plus Excellent critical thinking and decision-making skills A continuous improvement approach Innovative problem-solving ability Strong organizational skills with attention to detail The Regulatory Specialist will support the Laboratory Plastics Essentials business by working closely with global manufacturing sites including locations in Tijuana (MX), Monterrey (MX) and Roskilde (DE) to ensure overall product safety and regulatory compliance. TThe RA Specialist will also act as a regulatory consultant to ensure all products comply global and regional regulations and market needs (REACH/SVHC, California Proposition 65, RoHS). Ensure availability of up-to-date technical documentation and Standard Operating Procedures Work together with LPE global teams for supporting customer requests with related RA mailboxes Work with the global environmental compliance team to oversee the management of compliance information for all sourced materials, components and finished goods Support international registrations with related technical documentation Function as an RA subject matter expert on new product introductions, capacity expansion projects and custom product development and manufacturing Complete timely regulatory safety evaluations on customer complaints and manufacturing non-conformance activities for regulated products Provide regulatory input to QA in Deviations, CAPAs, Management Review and complaints Provide guidance regarding regulatory and performance test requirements for product claims and the design verification and validation of products (including sterilization, biocompatibility, labelling, clinical, and packaging validation)

Hace 4 horas en Tijuana

Especialista de Cumplimiento Regulatorio (ISO 13485) - Foránea

Thermo Fisher Scientific (Planta Tijuana)

A positive approach and motivated by challenges Team-player mentality Dedicated with the ability to handle tasks independently Flexibility to handle shifting priorities Confidence in collaborating with colleagues at all levels Strong written communication skills, with technical writing experience being a plus Excellent critical thinking and decision-making skills A continuous improvement approach Innovative problem-solving ability Strong organizational skills with attention to detail The Regulatory Specialist will support the Laboratory Plastics Essentials business by working closely with global manufacturing sites including locations in Tijuana (MX), Monterrey (MX) and Roskilde (DE) to ensure overall product safety and regulatory compliance. TThe RA Specialist will also act as a regulatory consultant to ensure all products comply global and regional regulations and market needs (REACH/SVHC, California Proposition 65, RoHS). Ensure availability of up-to-date technical documentation and Standard Operating Procedures Work together with LPE global teams for supporting customer requests with related RA mailboxes Work with the global environmental compliance team to oversee the management of compliance information for all sourced materials, components and finished goods Support international registrations with related technical documentation Function as an RA subject matter expert on new product introductions, capacity expansion projects and custom product development and manufacturing Complete timely regulatory safety evaluations on customer complaints and manufacturing non-conformance activities for regulated products Provide regulatory input to QA in Deviations, CAPAs, Management Review and complaints Provide guidance regarding regulatory and performance test requirements for product claims and the design verification and validation of products (including sterilization, biocompatibility, labelling, clinical, and packaging validation)

Hace 4 horas en Monterrey