Quality Systems Specialist II — FDA/ICH Compliance

RXinsider LTD.; Irvine (CA); On-site; USD 96,000 - 118,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. is seeking a Quality Specialist II to provide oversight of the Quality System and ensure compliance with FDA, ICH, and internal standards. You will review documentation, data, and manufacturing records to support product quality and safety.

The role requires a bachelor's degree with at least six years in a regulated industry, strong problem-solving, communication, and the ability to work independently with minimal supervision.

Qualifications

• Bachelor's degree or equivalent combination of education and experience required.
• A minimum of 6 years of experience in a regulated industry.
• Strong knowledge of quality systems, regulatory requirements, and data integrity principles.
• Excellent problem-solving, organizational, and communication skills.
• Ability to work independently with general supervision and manage multiple priorities.
• Relevant industry certification preferred.

Responsibilities

• Provide Quality oversight of the Quality System, including review of SOPs, protocols, reports, and manufacturing records.
• Perform timely review of data and documentation supporting batch release.
• Ensure compliance with FDA, ICH, and internal quality standards.
• Review records to ensure data integrity and accuracy.
• Support and approve investigations, including review of reports.
• Oversee equipment and software qualification, calibration, and validation activities.
• Collaborate with Corporate Quality to implement standardized processes and ensure compliance.
• Perform additional duties as assigned.

Skills

Quality systems knowledge

Regulatory knowledge

Data integrity principles

Problem-solving

Organizational skills

Communication skills

Independent work

Education

Bachelor's degree or equivalent

Job description

B. Braun Medical Inc. is seeking a Quality Specialist II to provide oversight of the Quality System and ensure compliance with FDA, ICH, and internal standards. You will review documentation, data, and manufacturing records to support product quality and safety.

The role requires a bachelor's degree with at least six years in a regulated industry, strong problem-solving, communication, and the ability to work independently with minimal supervision.