A Quality Systems & Compliance Leader responsible for driving quality system excellence and ensuring alignment between operations and regulatory requirements. This role plays a critical part in maintaining audit readiness, managing CAPAs, and promoting continuous improvement within a highly regulated manufacturing environment.

Client Details

• International Manufacture Company

Description

• Own and evolve the Quality Management System in line with industry standards and regulatory requirements (e.g. ISO 13485).

• Lead audit readiness and execution (corporate, customer, supplier, and regulatory).

• Drive end-to-end CAPA and NCR processes with operational impact.

• Promote a environment of quality through systems thinking, root-cause analysis, and preventive actions.

• Ensure that quality strategies are aligned with production and business goals.

• Act as a key voice in cross-functional teams to embed quality into every layer of the operation.

Profile

• Solid experience working with quality systems in regulated manufacturing (preferably ISO 13485 or similar).

• Track record in managing audits, handling CAPAs/NCRs, and driving systemic improvements.

• Familiarity with documentation control, complaint management, and compliance reporting.

• Experience in medical device, automotive or similar highly regulated sectors strongly preferred.

• Hands-on leadership style and process-oriented mindset.

• Strong interpersonal and communication skills.

• Self-starter with a proactive, prevention-first approach.

• Able to influence across departments and integrate into high-performing teams.

• Advanced English

• Location: Baja California (Tijuana, Mexicali, Ensenada, Tecate)

Job Offer

• Attractive compensation package