Supervisor de Sistemas de Calidad

Cardinal Health, Inc.; Chihuahua; Presencial; MXN 50,000 - 200,000; Jornada completa

Descripción de la vacante

A leading healthcare company in Chihuahua is seeking a Quality Engineering professional with 4-8 years of experience in medical device or pharma manufacturing. Responsibilities include managing quality planning, overseeing audits, and leading a team to ensure regulatory compliance. Ideal candidates have a Bachelor's degree and advanced English proficiency. An inclusive workplace that values diversity is promoted.

Formación

• 4-8 years of experience in medical device or pharma manufacturing industries.
• Solid communication skills are essential.
• Knowledge in ISO 13485, MDSAP, FDA, and GMP highly preferred.

Responsabilidades

• Manage product and service quality planning and evaluation.
• Coordinate actions for regulatory audits and technical visits.
• Lead a team towards achieving goals and ensure effective communication.

Conocimientos

Experience in medical device or pharma manufacturing

Advanced fluency in English

Strong communication skills

Educación

Bachelor’s degree in related field or equivalent work experience

Herramientas

ISO 13485

FDA regulations

GMP knowledge

Descripción del empleo

What Quality Engineering contributes to Cardinal Health

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Engineering manages product and service quality planning, evaluation and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.

Responsibilities

• Manages product and service quality planning, evaluation, process control, records, and document changes.
• Works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.
• Management of CAPA (Corrective Action and Preventive Action) to identify, investigate and resolve issues and prevent further or future incidences.
• Works with multiple QMS systems for data and record management to maintain regulatory compliance.
• Coordinate and lead actions for regulatory, customer and corporate audits and customer technical visits.
• Coordinate and oversees internal and external audits.
• Responsible for engaging and working with Operations, Maintenance and Engineering to achieve site savings goals.
• Creates Defect Training - Visual Aids.
• Motivate, guide, and direct a team or organization toward achieving a shared vision and goals. Provide effective communication, performance management, and employee development through training, coaching, and fostering a positive and collaborative work environment.

Qualifications

• 4-8 years of experience in medical device or pharma manufacturing industries
• Bachelor’s degree in related field, or equivalent work experience
• English: Advanced fluency
• Solid communication skills

Knowledge and experience working with the following is highly preferred:

• ISO 13485
• MDSAP
• FDA
• GMP

What is expected of you and others at this level

• Coordinates and supervises the daily activities of operations or business staff
• Administers and exercises policies and procedures
• Ensures employees operate within guidelines
• Decisions have a direct impact to work unit operations and customers
• Frequently interacts with subordinates, customers, and peer groups at various management levels
• Interactions normally involve information exchange and basic problem resolution

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.