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

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Quality Assurance Director