Quality Assurance Director

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 6000 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 Medicals website or on the site:This Fremont-based center focuses on product design and development supporting engineering innovation prototyping and process development for complex medical 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 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 duties and responsibilities:Provide strategic leadership for all Quality Assurance programs and policies to strengthen and continuously improve internal and external the Quality Assurance department in the design implementation and maintenance of systems for document and data change control training CAPA discrepancy handling and complaint guidance to all departments on quality and regulatory and maintain quality system procedures related to Quality department Quality Assurance and Regulatory Affairs review and approval of quality system the Quality Engineering support function and provide indirect support to Quality Inspection 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 the selection training and development of Quality personnel in accordance with company mentor train develop and evaluate Quality Improvement a robust Quality Management System compliant with FDA 21 CFR 820 ISO 13485 and customer customer satisfaction with product communications and documentation related to part revisions holds dimensional inquiries rejections changes qualifications validations audit data and other customer-required quality interpret and implement customer-required corrective actions for product quality process and procedure changes to improve product internal and external audits as well as CAPA :Bachelors 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 Device industry experience required. (Must)Strong knowledge of FDA ISO 13485 CAPA NCR and leading Quality Engineers in development and manufacturing -facing quality leadership driving quality system improvements and audit of process validation sampling plans and leadership communication and team development have aptitude to develop a functional and technical understanding of products to ensure that manufacturing and inspection processes are adequate to ensure appropriate product QualificationsASQ certification (CQE CQA CMQ/OE).Knowledge of Quality Management Systems (QMS) SPC statistics GMP and :Strong written and verbal communication skills with the ability to be an effective and persuasive speaker and to apply rational systems principles to solve practical problems and manage diverse variables in environments with limited to interpret and execute instructions provided in written verbal diagrammatic or schedule in basic computer operations including email record keeping and routine database activities with advanced skills in word processing spreadsheets and graphics people management skills including counseling coaching performance evaluation and team :Medical dental and vision benefits-effective date of hire!Company-paid life insurance and disability benefitsGenerous Paid time off and 10 paid Holidays401k Plan with Company MatchTuition ReimbursementVoluntary Universal Life and Long-Term CareVoluntary Legal PlanPet InsuranceHome Ownership ProgramWe 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