Sony Biotechnology Inc., based in San Jose, California, supplies advanced flow cytometry analysis and sorting technology for use in life science research. It markets products to private and public research institutions, pharmaceutical and biotechnology companies, and large medical centers. Over the years, Sony Biotechnology products have received numerous outstanding new product awards as well as technology awards including the Frost & Sullivan Emerging Technology award, and the Milestone Award. To learn more: .

Position Summary:

The Manager, Quality System and Compliance will provide leadership in the implementation, maintenance, and improvement of company-wide quality management systems, procedures and support processes. Proactively monitors the various elements of the quality system to help ensure compliance with quality system regulations and applicable national and international quality standards. Ensures processes and tools are established to ensure ongoing compliance with applicable requirements.

Responsibilities:

Responsible for developing, implementing, and managing SBT's quality management system supporting the following areas:

• Supply Chain including warehouse management
• Procurement including vendor management
• Service repair
• Research and manufacturing site (located in Bothell, WA)
  • Maintain current quality system and ISO certification
  • Responsible for leading, driving and enforcing quality program in support of the manufacturing team
  • Oversee quality activities in manufacturing operations (incoming testing, QC, lot release, etc.)
  • Secure and maintain requirements from business partner

• Provide hands-on ownership for quality systems improvement projects to ensure various elements of the quality system continue to support changing business needs and goals
• Creating or updating existing SOPs collaborating with departmental managers
• Maintain an effective risk-based NC/CAPA and complaints management process
• Support external customer requests for documentation / evidence of existing quality system
• Work closely with SBT Leadership Team in actively engaging cross functional teams as a catalyst to driving change and improvements
• Lead internal audits and drive continuous improvement
• Manage communication with regulatory bodies as needed with appropriate stakeholder input

Minimum Qualifications:

• 5 to 8 years of experience in FDA regulated industries
• Experience in pharma, biotechnology, or medical device operations
• 2+ years of experience in a management role with demonstrated leadership skills
• Experience in implementing QMS and adapting/updating new processes
• Experience leading quality system audits
• Strong communication and documentation skills
• Flexibility and adaptability
• All candidates must be authorized to work in the US

Preferred Qualifications:

• Direct experience with FDA QSRs, ISO 13485, MDD 93/42/EEC, ISO 14971, Canada Medical
• Experience in health hazard evaluation/analysis, product recalls and other field actions
• Project management experience

#LI-AP1

Sony is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, sex (including pregnancy), gender, national origin, citizenship, ancestry, age, physical or mental disability, military status, status as a veteran or disabled veteran, sexual orientation, gender identity or expression, marital or family status, genetic information, medical condition, or any other basis protected by applicable federal, state, or local law, ordinance, or regulation.

Disability Accommodation for Applicants to Sony Corporation of America

Sony Corporation of America provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures. For reasonable accommodation requests, please contact us by email at or by mail to: Sony Corporation of America, Human Resources Department, 25 Madison Avenue, New York, NY 10010. Please indicate the position you are applying for.