Quality Assurance Director

Viant Medical; Fremont (CA); On-site; USD 200,000 - 240,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k Plan with Company Match

Paid time off and holidays

Tuition Reimbursement

Voluntary Life and Long-Term Care

Pet Insurance

Home Ownership Program

Job summary

Viant Medical in Fremont, California, is seeking a Director of Quality Assurance to lead a quality engineering team of about 15 and to oversee the company’s Quality Management System across both product development and manufacturing operations.

The candidate must have deep FDA 21 CFR 820 and ISO 13485 expertise, strong leadership, and a track record of driving CAPA, audits, change control, and regulatory compliance while partnering with customers and suppliers to ensure product quality.

Qualifications

• Bachelor's degree in Engineering, Quality, or related field.
• 10+ years of quality experience in regulated manufacturing and development environments.
• 5+ years leading quality teams in medical device or related industries.
• Strong knowledge of FDA and ISO 13485, CAPA, NCR, and audits.
• Customer-facing quality leadership experience.

Responsibilities

• Provide strategic leadership for Quality Assurance programs and policies.
• Lead design, implementation, and maintenance of document control, training, CAPA, discrepancy, and complaint systems.
• Guide all departments on quality and regulatory requirements.
• Develop and maintain quality system procedures and lead QA/RA document reviews.
• Manage Quality Engineering support and assist Quality Inspection teams.
• Partner with management to drive KPIs and process adherence.
• Collaborate with customers and suppliers on quality matters and maintain relationships.
• Direct selection, training, and development of QA personnel; coach and mentor.
• Maintain QMS compliant with FDA 21 CFR 820 and ISO 13485; ensure customer satisfaction.
• Oversee audits, CAPA programs, changes, and responses to customer quality data.

Skills

Leadership

Communication

People management

Coaching

Team development

Education

Bachelor's degree in Engineering, Quality, or related field

Tools

CAPA management

Document control systems

Job description

About the company:

Viant is a global medical device partner providing design, development, manufacturing, and assembly services through capabilities in materials, plastics, metals, extrusion, and automation. With nearly 6,000 employees across 24 locations worldwide, it delivers high-quality, life-enhancing products with the scale and expertise to bring devices to market efficiently. Learn more at Viant Medical’s website or on LinkedIn.

About the company:

Viant is a global medical device partner providing design, development, manufacturing, and assembly services through capabilities in materials, plastics, metals, extrusion, and automation. With nearly 6,000 employees across 24 locations worldwide, it delivers high-quality, life-enhancing products with the scale and expertise to bring devices to market efficiently. Learn more at Viant Medical’s website or on LinkedIn.

About the site:

This Fremont-based center focuses on product design and development, supporting engineering innovation, prototyping, and process development for complex medical devices.

About the role:

The Director of Quality Assurance is a senior, highly responsible leadership role overseeing all aspects of the Quality Management System (QMS). In this role you will Lead and develop a team of approximately 15 Quality Engineers supporting both product development and manufacturing operations.

This position requires strong expertise in medical device manufacturing, customer engagement, regulatory compliance, and organizational leadership, with deep knowledge of quality systems in accordance with FDA 21 CFR 820 and ISO 13485. The Director will lead strategic quality initiatives, ensure regulatory compliance, drive continuous improvement, and serve as a key partner to internal teams, customers, and suppliers.

Essential duties and responsibilities:

• Provide strategic leadership for all Quality Assurance programs and policies to strengthen and continuously improve internal and external quality.
• Lead the Quality Assurance department in the design, implementation, and maintenance of systems for document and data change control, training, CAPA, discrepancy handling, and complaint handling.
• Provide guidance to all departments on quality and regulatory requirements.
• Develop and maintain quality system procedures related to Quality department responsibilities.
• Lead Quality Assurance and Regulatory Affairs review and approval of quality system documentation.
• Manage the Quality Engineering support function and provide indirect support to Quality Inspection teams.
• Partner closely with management to ensure adherence to documented processes and development of key performance indicators (KPIs).
• Collaborate with customers and suppliers on quality-related matters while maintaining strong business relationships.
• Direct the selection, training, and development of Quality personnel in accordance with company policies.
• Coach, mentor, train, develop, and evaluate Quality Improvement personnel.
• Maintain a robust Quality Management System compliant with FDA 21 CFR 820, ISO 13485, and customer requirements.
• Ensure customer satisfaction with product quality.
• Manage communications and documentation related to part revisions, holds, dimensional inquiries, rejections, changes, qualifications, validations, audit data, and other customer-required quality information.
• Review, interpret, and implement customer-required corrective actions for product quality issues.
• Implement process and procedure changes to improve product quality.
• Oversee internal and external audits, as well as CAPA programs.

Qualifications:

• Bachelor's degree in Engineering, Quality, or related field.
• 10+ years of Quality experience in a regulated manufacturing and development environments (Medical Device, Pharmaceutical, Biologics)
• 5+ years leading Quality teams.
• Medical Device industry experience required. (Must)
• Strong knowledge of FDA, ISO 13485, CAPA, NCR, and audits.
• Experience leading Quality Engineers in development and manufacturing environments.
• Customer-facing quality leadership experience.
• Experience driving quality system improvements and audit readiness.
• Knowledge of process validation, sampling plans, and statistics.
• Strong leadership, communication, and team development skills.
• Must have aptitude to develop a functional and technical understanding of products to ensure that manufacturing and inspection processes are adequate to ensure appropriate product performance.

Preferred Qualifications

• ASQ certification (CQE, CQA, CMQ/OE).
• Knowledge of Quality Management Systems (QMS), SPC, statistics, GMP, and GLP.

Skills:

• Strong written and verbal communication skills, with the ability to be an effective and persuasive speaker and negotiator.
• Ability to apply rational systems principles to solve practical problems and manage diverse variables in environments with limited standardization.
• Ability to interpret and execute instructions provided in written, verbal, diagrammatic, or schedule formats.
• Proficient in basic computer operations, including email, record keeping, and routine database activities, with advanced skills in word processing, spreadsheets, and graphics software.
• Strong people management skills, including counseling, coaching, performance evaluation, and team leadership.

Benefits:

• Medical, dental, and vision benefits-effective date of hire!
• Company-paid life insurance and disability benefits
• Generous Paid time off and 10 paid Holidays
• 401k Plan with Company Match
• Tuition Reimbursement
• Voluntary Universal Life and Long-Term Care
• Voluntary Legal Plan
• Pet Insurance
• Home Ownership Program

We offer market competitive compensation. Potential salary range for this role is $200k-$240k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.