Quality Assurance Manager I

Location

Fontana, CA | United States

Job description

Quality Assurance Opportunity with DHL for an exciting new line of Medical Device business in Fontana, CA (onsite position).

Experience Desired in these areas:

* Medical Device Warehousing & Distribution

* Manufacturing Component Part Inspections

* Freezer/Cooler Storage & Temperature Monitoring

* Clean Room Maintenance & Particulate Monitoring

Quality Assurance Manager I

Are you looking for a challenging and rewarding opportunity in a fast-paced environment?Do you take an analytical approach to design complex and innovative solutions that exceed customer expectations and directly impact a growing business?Do you enjoy being part of a passionate team that works with stakeholders from across the business to create and implement the best solutions for our customers?

Job Description

Manage and coordinate all aspects of quality assurance activities with various levels of risk and complexity within a variety of scopes across a single site / multiple sites and / or single or multiple customers . Confirm requests for quality support from the site and communicate policies and procedures. Expert regarding selected governmental regulations for the site(s). Proactive liaison with customer for quality assurance across site(s). Develop, manage, and oversee site quality resources. Support global and cross-sector Quality and Regulatory initiatives, as required. Support validated processes as applicable for regulated hardware, equipment, and software systems.

• Oversee the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.
• Oversee the licenses, permits, and registrations process.
• Manage and provide oversight for regulatory compliance with regards to products handled and services performed at site by assessing performance to cGxP, the contract (OSA, QAA/ TA), and customer requirements as applicable; reporting the results to executive management
• Ensure that systems and equipment are validated (if applicable) and change control processes maintained
• Hire, train, and develop quality associates.
• Monitor the training and development of site associates to ensure compliance to processes and regulations.
• Work in coordination with continuous improvement team to focus/direct continuous improvement activities/workshops
• Review and provide recommendations on regulatory, customer and 3rd party audits.
• Review and identify trends within the quality assurance metrics for the organization.
• Primary customer contact for QA related issues/initiatives as needed.
• Develop, distribute and maintain regular management reports
• Manage site suppliers and prepare, receive, and act on audits
• Provide Business Development support and represent DHL in customer events and meetings as required

Required Education and Experience

• Bachelor’s degree in a related field or 5-7 years relevant work experience, required
• Graduate’s degree in related field, preferred
• Certification related to quality control (RAC, Six-Sigma, etc.), preferred

Our Organization has a business casual environment and focuses on teamwork, associate development, training, and continuous improvement. We offer competitive wages, excellent affordable insurance benefits (including health, dental, vision and life), 401K plan, paid vacation and holidays.

Our Organization is an equal opportunity employer.

#LI-Onsite

Job tags

Salary