Supplier Quality Engineer

Job Title : Supplier Quality Engineer

Location : Irvine, CA (Onsite)

Duration : 12+ Months Contract

Experience Required : 5+ Years

Job Summary :

The Supplier Quality Engineer will be responsible for managing and maintaining quality agreements with external suppliers, ensuring compliance with global quality standards and regulatory requirements. This role requires strong knowledge of Quality Systems, cGMPs, and relevant international regulations, along with excellent communication and organizational skills.

Key Responsibilities :

Prepare new quality agreements with suppliers and vendors in alignment with company and regulatory standards.

Update, review, and maintain existing supplier quality agreements to ensure ongoing compliance.

Upload and manage global quality agreements within the document repository system.

Generate and maintain key performance metrics related to supplier quality agreements.

Collaborate cross-functionally with internal teams and external suppliers to address quality issues and ensure alignment with corporate quality standards.

Ensure all supplier quality activities comply with applicable GxP, FDA, MHRA, EU, and ICH regulations.

Participate in supplier audits, assessments, and continuous improvement initiatives.

Support documentation and reporting processes in accordance with SOPs and regulatory requirements.

Maintain high attention to detail and accuracy in all documentation and communication.

Carry out responsibilities in accordance with company policies, procedures, and local, state, and federal laws.

Required Qualifications :

Bachelor's degree in a scientific, engineering, or related discipline (minimum 4-year degree).

Minimum of 5 years of experience in supplier quality management within a regulated industry (pharmaceutical, biotech, or medical device preferred).

Strong understanding of Quality Systems, cGMPs, ICH, EU, FDA, and MHRA regulations.

Proven experience in drafting, reviewing, and managing supplier quality agreements.

Proficiency in business and scientific software applications, including advanced MS Word and document management tools.

Excellent written and verbal communication skills, with strong command of business English, grammar, and technical writing.

Strong attention to detail, organization, and time management skills.

Demonstrated ability to work effectively both independently and collaboratively across teams.

Preferred Skills :

Experience with electronic quality management systems (eQMS).

Knowledge of supplier qualification and auditing processes.

Familiarity with global supply chain and manufacturing processes in life sciences.

Ability to analyze data and generate meaningful quality metrics.