Regulatory Compliance and Quality Assurance Manager

2 weeks ago

Pleasanton, California, United States Omron Automation Full time

Join OMRON's Innovative Team

Omron Robotics and Safety Technologies, Inc. (ORT) stands at the forefront of intelligent vision-guided robotics systems and services. We focus on creating solutions that address social needs within the global automation landscape. Our robotics systems deliver exceptional performance and economic advantages throughout the production lifecycle, empowering clients to achieve precision, quality, and productivity in their assembly, handling, and packaging operations while fostering a safer and more sustainable environment.

We are dedicated to advancing new electronics, mechanics, and software across a diverse range of robotic platforms, including autonomous mobile robots, articulated robots, and parallel link robots. Our product development teams are driven by a passion for innovation and a proven track record of successfully launching products in the global market, transforming the interaction between humans and machines.

As a subsidiary of Omron Corporation, a global technology leader with over 90 years of success and an annual revenue of $8 billion, we are seeking a dynamic and motivated Compliance & Engineering Quality Manager to lead a talented and diverse team in the creation of cutting-edge robotic technologies. The ideal candidate will take charge of a mid-sized team, providing guidance, prioritization, and professional development to those engaged in the design, documentation, and testing of both mobile and stationary robots, along with their associated components and equipment.

Key Responsibilities:

  • Lead cross-functional teams to ensure that robotic products align with market requirements. Collaborate proactively with engineering project management and design teams, review design data, and formulate compliance policies to accurately capture the Compliance & Engineering Quality team's scope of work within project schedules and timelines.
  • Engage in technical design reviews to ascertain compliance requirements, communicate these to the project team, participate in design decisions impacting compliance, and estimate workloads for compliance-related tasks.
  • Influence product design, quality, testability, and certification initiatives to ensure safety, compliance, and high quality. Assist the team in generating New Product Introduction (NPI) process documents and product manual content.
  • Oversee and support product evaluations with third-party entities, both onsite and at external testing facilities. Collaborate with Product Development Teams to ensure the availability of samples for testing and the aggregation of all necessary design documentation.
  • Assist engineering teams with internal Design Verification Testing (DVT) of functional and product safety specifications. Coordinate and, where necessary, conduct functional testing in accordance with product safety standards, generating detailed test reports and datasheets as appropriate.
  • Support the team in conducting hazard analyses and risk assessments for all robotic products, both in development and legacy.
  • Review and approve design updates, test plans, and verification test reports for NPI. Provide support for legacy products, including design updates, feature enhancements, and addressing field-failure issues.
  • Manage the creation of compliance-related project documentation and provide customer-facing compliance language for technical publication manuals.
  • Establish and maintain a compliance database for pre-scans, test reports, technical construction files, country certificates, Declarations of Incorporation/Conformity (DoI/DoC), and final certifications. Ensure the accuracy and correctness of all required agency documentation.
  • Interpret standards and rulings, challenging agency decisions when necessary.
  • Guide Product Development Teams through all phases of the agency certification process, creating process and procedure documents to support certification programs as needed. Collaborate with certification bodies and compliance agencies to obtain and renew certificates, coordinate in-country testing, and ensure ongoing compliance.
  • Coordinate with Manufacturing Engineering and Operations teams to update product compliance labels with the appropriate country logos and approval numbers.
  • Ensure that environmental regulatory standards are met and effectively implemented to complete projects on time while achieving quality, cost, and availability objectives.
  • Work with team members to document environmental compliance by completing approval applications and maintaining environmental files.
  • Engage with regulatory agencies to stay informed about upcoming changes in environmental regulations and their implications for new and legacy products, communicating these changes to cross-functional teams.

Qualifications:

  • Graduate degree in Engineering or a Bachelor's degree in Engineering with equivalent experience.
  • Over 10 years of progressive experience in working with commercial products to achieve regulatory certification.
  • Exceptional communication skills across technical and management domains.
  • Strong problem-solving capabilities with a demonstrated ability to navigate technical issues and conflicts towards resolution.
  • Proven experience in design leadership throughout the product development lifecycle.
  • Familiarity with all phases of product development, including design, implementation, debugging, verification & validation, qualification, and transfer to manufacturing.
  • Experience in verifying hardware products for compliance with global product standards.
  • Demonstrated experience collaborating with third-party certifying bodies and testing laboratories for formal certification and verification.
  • Knowledge of designing for EMC/EMI compliance during development and addressing radiated emissions issues.

Omron is committed to fostering a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, national origin, age, disability, or genetics. This policy applies to all employment terms and conditions.

We welcome applicants from all backgrounds and encourage those who may not meet every single requirement to apply, as we value diverse experiences and perspectives.

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