Overview
Quality Director Jobs in San Diego, CA at Foxconn Baja California
Title: Quality Director
Company: Foxconn Baja California
Location: San Diego, CA
About the Company
Foxconn Baja California is part of Hon Hai Precision Industry Co., Ltd., the world’s largest electronics manufacturing company and a global leader in advanced manufacturing solutions. Our Tijuana operations support high-complexity manufacturing programs across multiple industries, including the rapidly expanding Medical Devices and MedTech sector.
As part of our global growth strategy, Foxconn Baja California is strengthening its leadership structure to support new business expansion, operational excellence, and world-class quality systems for highly regulated medical manufacturing environments.
Position Overview
We are seeking a highly strategic and results-driven Quality Director to lead corporate-level quality initiatives and support the global expansion of our Medical Device manufacturing operations.
Seeking MedTech professionals in San Diego – Cross-border opportunity between Tijuana and San Diego.
This executive leadership role will be responsible for driving quality strategy, regulatory compliance, operational excellence, supplier quality performance, and customer satisfaction across current and future MedTech business operations. The position will play a critical role in supporting new business development, customer launches, global expansion initiatives, and the establishment of scalable quality systems aligned with international standards.
The ideal candidate brings deep expertise in Medical Device manufacturing, strong leadership capabilities, and proven experience supporting high-growth manufacturing organizations within complex global environments.
Key Responsibilities
- Lead the overall Quality strategy for Medical Device and MedTech manufacturing operations across corporate and site-level initiatives.
- Drive compliance with FDA, ISO 13485, GMP, and other international regulatory and quality standards.
- Develop and implement scalable Quality Management Systems (QMS) to support global business expansion and operational growth.
- Partner with executive leadership teams on strategic initiatives, customer engagement, and new business opportunities.
- Lead quality readiness activities for new product introductions (NPI), customer transfers, and new manufacturing site expansions.
- Oversee Supplier Quality Management strategies to ensure robust supplier performance and regulatory compliance across the supply chain.
- Direct internal and external audits, customer audits, and regulatory inspections while ensuring effective corrective and preventive actions (CAPA).
- Establish and monitor corporate quality KPIs, risk management strategies, and continuous improvement initiatives.
- Support business development activities by participating in customer visits, technical discussions, capability presentations, and quality strategy alignment.
- Build and develop high-performing Quality teams while promoting a culture of accountability, operational excellence, and continuous improvement.
- Collaborate cross-functionally with Operations, Engineering, Program Management, Regulatory Affairs, and Global Leadership teams.
Qualifications
- Bachelor’s degree in Engineering or related technical field required. Master’s degree is preferred.
- 10+ years of progressive leadership experience within Quality organizations in Medical Device, MedTech, or highly regulated manufacturing industries.
- Strong experience supporting global manufacturing operations and corporate-level quality strategies.
- Proven expertise in:
- FDA regulations
- ISO 13485
- GMP environments
- Risk Management
- CAPA systems
- Supplier Quality
- Regulatory Audits
- Continuous Improvement methodologies
- Demonstrated experience supporting new business development, customer acquisition, and operational expansion initiatives.
- Strong background in high-volume and high-complexity manufacturing environments.
- Experience leading multicultural and cross-functional teams in global organizations.
- Exceptional leadership, strategic thinking, decision-making, and communication skills.
- Advanced English communication skills required.
Preferred Experience
- Experience within catheter, disposable medical device, or advanced MedTech manufacturing operations.
- Experience supporting multinational customers and global regulatory environments.
- Background in large-scale manufacturing operations and corporate transformation initiatives.
- Lean Manufacturing and Six Sigma certifications are highly preferred.
Why Join Foxconn Baja California?
- Opportunity to lead strategic Quality initiatives with global impact.
- Be part of a rapidly expanding Medical Manufacturing organization.
- Collaborate with executive leadership in a high-growth environment.
- Influence the future of advanced manufacturing and MedTech operations globally.
- Join one of the world’s most innovative and operationally advanced manufacturing companies.
