Supervisor de Calidad

Medline Industries; Nuevo Laredo; Presencial; MXN 801,000 - 1,069,000; Jornada completa

Descripción de la vacante

A leading medical manufacturing company in Nuevo Laredo is seeking a Quality Manager to oversee quality assurance processes and ensure compliance with QSR and GMP standards. The ideal candidate will have at least 3 years of experience in regulated industries, knowledge of FDA guidelines, and strong auditing skills. Responsibilities include managing staff performance, conducting Line Audits, and maintaining communication with business partners. The role may require up to 10% travel.

Formación

• Experience with QSR, GMP, and ISO compliance. Minimum 3 years required.
• Ability to lift up to 50 pounds and work in varying temperatures.
• Intermediate knowledge of ISO14551 and ANSI/ASQCZ1.4.

Responsabilidades

• Manage employee performance, attendance, and reviews.
• Train inspectors on Quality System Regulation.
• Conduct Line Audits and resolve quality problems.

Conocimientos

Quality Systems Regulation (QSR)

FDA guidelines

Auditing Skills

Medical Devices knowledge

Educación

High School Diploma or equivalent

Descripción del empleo

Job Description

• Manage all performance, attendance, pay administration and employee reviews/corrective actions.
• Monitor and evaluate subordinate performance and make recommendations for merit increases.
• Maintain a good working relationship and open communications with business partners.
• Train inspectors on Quality System Regulation (QSR) and relevant company policies and procedures.
• Build and maintain employee morale and motivation, and ensure the team is appropriately staffed with required competencies.
• Perform Line Audits to ensure acceptable product is being manufactured to specification.
• Conduct routine and non-routine analysis of in-process materials, raw materials, and finished goods.
• Investigate and resolve ongoing quality problems, such as defective raw materials and finished goods.
• Develop continuous improvements and/or cost savings of existing processes and products.
• Responsible for management of day-to-day activities and outcomes of a group of employees.
• Hire staff, recommend pay increases, perform performance reviews, train and develop staff, estimate personnel needs, assign work, meet completion dates, interpret and ensure consistent application of organizational policies.

Minimum Job Requirements:

Education

• High School Diploma or equivalent.

Work Experience

• At least 3 years of experience working with QSR/GMP/ISO requirements and compliance or other regulated industries.

Knowledge / Skills / Abilities

• Intermediate level understanding of FDA/ QSR/ ISO14551, ISO9001, ISO13485 guidelines.
• Intermediate level knowledge of ANSI/ ASQCZ1.4-current revision.
• Intermediate Auditing Skills.
• Basic knowledge of Quality Systems Regulations and Medical Devices.
• Position requires: Ability to lift up to 50 pounds; Sit, walk or stand for prolonged periods of time with frequent bending and kneeling; Display specific vision abilities including, close vision, distance vision, depth perception and ability to adjust focus; Ability to work in hot and cold environments, (32F – 95F); Ability to work at extended heights.
• Position requires up to 10% travel

Preferred Job Requirements:

Work Experience

• Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.