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Quality Control Manager

hace 2 semanas

Ciudad Juárez, México Ambu A tiempo completo

**A global job position with an impact**:
We are growing and expanding our Manufacturing Site in Mexico In the job as Quality Control Manager, you will have the opportunity to actively support the organization ensuring that our manufacturing site runs as needed to have the growth expected of the products we make in Mexico, excel in your own daily tasks and responsibilities, and experience a very varied working day in a dynamic.

**Required skills**:

- Develop, implement, and maintain quality control policies and procedures.
- Provides supervision of the QC Operations ensuring allocation of adequate resources for

Shop floor QC activities.
- Applies expertise in manufacturing QC concepts and business knowledge to act as the

primary point of contact for their team and the first-line escalation point in areas of their
responsibility.
- Leads or support quality improvement initiatives leads to continuous improvements / cost.
- Assignment of training curricula to Quality personnel based on the Job Description and

ensure training is up to date.
- Provides training, coaching, and mentorship to their team and peers as applicable. Works

with their team to identify areas for improvement, reduce blind spots, and give opportunities
for increasing responsibility as appropriate.
- Maintain the quality control objectives in alignment with the objectives of the plant.
- Promotes and supports the implementation of quality, product and process improvement

projects.
- Revises / analyzes if the current products and processes (including performed actions or

decisions) comply with the regulations, such as the QSRs, ISO 13485, etc.
- Serves as Subject Matter Expert in audits and inspections for their area of responsibility.
- Revises and approves the answers to internal and external audit observations ton ensure the

compliance with the internal procedures and applicable regulations
- Establishes and properly maintains the required documentation of quality control activities
- Defines, monitors and administers the budget of the quality control department/cost
- Collaborates with Engineering and with the Operations departments to develop, conduct and

approve validation strategies of products and processes.
- Revises and approves the investigations, bounding, documentation, revision and approval of

the non-conformities (NCRs), preventive and corrective actions (CAPAs), customer
complaints and escalation of quality problems when applies.

**Qualifications**:

- Bachelor's degree in a related field
- 7+ years of experience working in Quality
- Experience on medical device industry and understanding of cGMP, ISO13485 and CFR part

820.
- Good analytical thinking and problem-solving mindset.
- Ability to work, interact, and communicate effectively with others.
- Effective verbal and written communication skills.
- Experience working in manufacturing environment.

**Authority**:

- Final release of Ambu A/S and King System products.
- Reject to release the product/lot and escalate any problems to NCR/CAPA
- Reject the release of product/lot, if disagreeing with the disposition of a NCR or CAPA
- Stop manufacturing if production represents a quality risk
- Put product on hold
- Initiate CAPAs and NCRs
- Approve and reject change requests

**Work Environment**:
This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.

**How to Apply**:
About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.