Quality Assurance Engineer
hace 6 meses
Job Description Summary
The Quality Engineer is responsible for providing support to the operative personnel for in-process
inspection, as well as the manufacturing related departments. The Quality Engineer role is to evaluate and
improve the QA acceptance activities and testing to ensure that medical devices being manufactured comply
with all the established requirements. He serves as a lead and support to investigations were deviations
have/ or can occur to the medical devices and require an action plan to prevent further impact on product,
this with the knowledge on regulations, standards, procedures, and by having a risk-based approach when
determining the corrections and actions required to ensure the quality and compliance of the product.
**Job Description**:
How about becoming a maker of possible?
For more than 125 years, we’ve pursued our Purpose of advancing the world of health. We relentlessly commit to a promising future by developing innovative technologies, services and solutions, helping the healthcare community improve safety and increase efficiency. It takes the imagination and passion of all of us at BD, from the manufacturing to marketing of our products, to look at the impossible and find transformative solutions to turn dreams into possibilities - For people today, tomorrow and beyond. Become a maker of possible with us
Support for Inspection and Manufacturing processes
Performs evaluation, improvement, and implementation of test method and inspection procedures
used for acceptance activities, based on established standards, and established documents.
Establishes and executes test method validations.
Reviews and approves of process/ product validations.
Develops Risk Analysis for Waivers/ Reworks/ Sorts/ Use as is/ etc.
Customer Complaints
Coordinates periodic meetings to evaluate customer complaints trend and action plans to reduce
recurrence of failures.
Provides support to respond customer complaint investigations as team member.
Evaluates complaints to determine applicability to manufacturing/ supplier.
Performs investigations to address failures and/or trends reported by customers.
Investigations/Action Plans
Leads/supports CAPA investigations to address root cause and generate action plans.
Performs corrective/ preventive actions as well as effectiveness check for action plans.
Investigates potentials for failure to detect risk to the product/ process.
External Rejections
Investigates and responds external rejection reports (SCARs/ QNs/ etc).
Reviews external rejection reports to generate action plan to reduce/mitigate incidences.
Miscellaneous
Participates as support in projects for changes (design and non-design).
Develops and updates the Process Failure Mode Effect Analysis (FMEA).
Evaluates and proposes changes that contribute to the department costs reduction.
Participates actively in the implementation of quality programs that encourage a prevention
environment and defects or problems detection.
Participates actively in the verification of the quality system to ensure the maintenance record in
ISO 13485 certification, compliance of current Good Manufacturing Practices (GMP) and adherence
to regulations and internal, divisional, corporate, and regulatory agencies policies.
Proposes or recommends changes for continuous improvement of processes, products,
procedures, and methods.
Attends training courses, and or of self-professional improvement.
Any other task assigned by immediate Supervisor or Manager.
Finished bachelor’s degree, in the Engineering area preferably.
2 years in a similar position preferably.
Knowledge of statistics techniques, and statistical process control (SPC).
Data analysis, problem solving, time management, teamwork, leadership skills.
Math abilities at professional level, statistical interpretation for decision making.
Language Skills: Intermediate English
“BD values equity in the workplace without discrimination for any disability, class, ethnicity, age, religion, gender identity or sexual orientation.”
Primary Work Location
MEX Nogales South - Parque Industrial El Cid
Additional Locations
Work Shift
-
Highly Skilled Test and Quality Assurance Engineer
hace 3 semanas
Parque Industrial Querétaro, México HARMAN International A tiempo completoAbout the JobHARMAN International is seeking a highly skilled Test and Quality Assurance Engineer to join our team.
-
Quality Assurance Engineer H/m
hace 3 meses
Industrial, México Safran A tiempo completo**Description du poste**: Quality Assurance Engineer is responsible for surveillance all the compliance, effectiveness and quality of the shop processes with the applicable aeronautical authorities, OEM, customers, Quality Management System, and company procedures requirements. **Description compl�mentaire**: - Verify that SAESA's Quality System is...
-
Quality Assurance Engineer H/m
hace 6 meses
Industrial, México Safran A tiempo completo**Description du poste**: Quality Assurance Engineer is responsible for surveillance all the compliance, effectiveness and quality of the shop processes with the applicable aeronautical authorities, OEM, customers, Quality Management System, and company procedures requirements. **Description compl�mentaire**: - Verify that SAESA's Quality System is...
-
Sr. Supplier Quality Engineer
hace 6 meses
Parque Industrial, México BD A tiempo completoJob Description Summary Develop, implement, and manage the components and materials Supplier Management Program. Establish an effective communication and interaction, with suppliers focused on solving quality issues. Participate on the identification, selection, evaluation, approval and certification of supplier components and materials. Coordinate the...
-
Documentation Engineer
hace 7 meses
Parque Industrial, México BD A tiempo completoJob Description Summary The Documentation Engineer participates in all aspects of the Electronic Documentation System. Participates and assists in creating documents according to established standards. Assists in the fulfillment of departmental and plants goals. Develops his/her skills to train and lead. Participates in Lean Thinking...
-
Quality Compliance Lead
hace 6 meses
Parque Industrial, México BD A tiempo completoJob Description Summary The purpose of this position is to assist the Quality Assurance Management in maintaining compliance with Laws and Regulations of the countries we sell product to, as well as to comply to applicable Quality Standards, such as ISO 13485. This position is mainly responsible of coordinating the processes of Quality System Internal...
-
Quality Engineer
hace 6 meses
Parque Industrial Santa Fe, México LKY Industrial Services A tiempo completoIn conjunction with more senior engineers, plans, develops and implements techniques and programs to ensure that quality levels are maintained in accordance with the organization’s quality standards. - Collaborates to establish specifications, controls and quality metrics, including participation in reviewing PFMEA and Control Plans. Monitor, identify,...
-
Quality Engineer
hace 1 mes
Parque Industrial los Fuentes, México VALUTECH OUTSOURCING S.A DE C.V A tiempo completo**Job Responsabilities** - Ensure product quality meets customer requirements by monitoring and addressing production issues. - Develop and lead continuous improvement projects to enhance product quality and processes. - Define, measure, and monitor statistical controls in quality areas. - Monitor quality failures in the CQC area, track the effectiveness of...
-
Quality Engineer Sr
hace 2 meses
Parque Industrial Querétaro, Qro., México IMI Precision Engineering A tiempo completo**Area** Quality **Work type** Full Time **Experience** Professionals **Sector** Transport **Reference** IPE-645477 **Location** Parque Industrial Querétaro, Mexico **Work Environment** On-site **Platform** Life Technology **Overview**: **IMI plc** IMI plc is a sector focused organisation at the forefront of delivering motion and fluid...
-
Senior Process Engineer
hace 6 meses
Parque Industrial Cucapah, México Doncasters A tiempo completo**Are you an experienced process engineer? Do you have strong analytical and problem-solving skills?** Look no further as at Doncasters we have an exciting opportunity for a Senior Process Engineer to join our team in Mexicali, Mexico. **The Role** The Senior Process Engineer will provide engineering and technical expertise to evaluate and implement...
-
Laboratory R&d Test Engineer
hace 3 meses
Parque Industrial Intermex Sur, México COFICAB CD JUAREZ A tiempo completo**Position objective**: Responsible for reviewing and authorizing the reports made by technicians in accordance with quality standards and instructions and those of International Organizations, following up on sample requests and carrying out technical tests that require specialization. Participate in activities related to safety, quality and environmental...
-
Supervisor de Mantenimiento de Equipo
hace 7 meses
Parque Industrial, México BD A tiempo completoJob Description Summary Responsible for maintaining the equipment in good conditions to produce. Supervise and coordinate the activities of preventive and corrective maintenance, as well as the maintenance personnel under its supervision, according to safety standards and established procedures. Coordinates and follows up improvement projects and repairs of...
-
Supervisor de Mantenimiento de Equipo
hace 2 meses
Parque Industrial, México BD A tiempo completoJob Description Summary Responsible for maintaining the equipment in good conditions to produce. Supervise and coordinate the activities of preventive and corrective maintenance, as well as the maintenance personnel under its supervision, according to safety standards and established procedures. Coordinates and follows up improvement projects and repairs of...
-
AME SMT Engineer Jr.
hace 7 meses
Parque Industrial Querétaro, México HARMAN International A tiempo completoA Career at HARMAN As a technology leader that is rapidly on the move, HARMAN is filled with people who are focused on making life better. Innovation, inclusivity and teamwork are a part of our DNA. When you add that to the challenges we take on and solve together, you’ll discover that at HARMAN you can grow, make a difference and be proud of the...
-
Principal Product Value Analytics Engineer
hace 7 meses
Parque Industrial Querétaro, México HARMAN International A tiempo completoA Career at HARMAN As a technology leader that is rapidly on the move, HARMAN is filled with people who are focused on making life better. Innovation, inclusivity and teamwork are a part of our DNA. When you add that to the challenges we take on and solve together, you’ll discover that at HARMAN you can grow, make a difference and be proud of the...
-
Quality Engineer
hace 6 meses
Col. Industrial Vallejo, México Tenneco A tiempo completoGarantizar la conformidad de los productos y procesos con los requerimientos de cliente e internos. Coordinando al equipo multidisciplinario, liderando proyectos de reducción de scrap y solución de problemas. - Promover y asegurar el cumplimiento en piso del sistema de gestión de calidad IATF e ISO 9000 con especial atención a: - Procedimiento de...
-
Process Engineer
hace 1 mes
Parque Industrial los Fuentes, México VALUTECH OUTSOURCING S.A DE C.V A tiempo completo**Job Responsabilities** - Develop, establish and document the repair process, through procedures, training manuals and work instructions. - Maintain the repair repeat and bounce rate, down time, yield and scrap metrict. - Keep the capacity model updated. - Generate training manuals for each operations in the repair process. - Participate in continuos...
-
Hardware Validation Engineer
hace 7 meses
Parque Industrial Querétaro, México HARMAN International A tiempo completoHARMAN’s engineers and designers are creative, purposeful and agile. As part of this team, you’ll combine your technical expertise with innovative ideas to help drive cutting-edge solutions in the car, enterprise and connected ecosystem. Every day, you will push the boundaries of creative design, and HARMAN is committed to providing you with the...
-
Ing. de Calidad
hace 6 meses
Parque Industrial GP Escobedo SIC, México HellermannTyton A tiempo completo**Somos una empresa internacional, líder de inyección de plástico, estamos en busca de talento como el tuyo para la posición**: **"Quality Engineer"** **Formación Académica**: Diseño industrial o ingenierías mecánica, mecatrónica, eléctrica, de control y automatización o afines. - **Inglés Intermedio Deseable**_ **Conocimiento en Lean...
-
Planeador de Producción Exp en Inyección de
hace 6 meses
Parque Industrial GP Escobedo SIC, México HellermannTyton A tiempo completo**Somos una empresa internacional, líder de inyección de plástico, estamos en busca de talento como el tuyo para la posición**: **"Quality Engineer"** **Formación Académica**: Diseño industrial o ingenierías mecánica, mecatrónica, eléctrica, de control y automatización o afines. - **Inglés Intermedio Deseable**_ **Conocimiento en Lean...