FDA and Environmental Compliance Reporting Coordinator

Responsibilities

JOB DESCRIPTION

FDA Responsibilities

• Prepare and submit FDA/CDRH reports for new laser products, product modifications, and manufacturing location changes.
• Manage and maintain all accession numbers and ensure accurate linkage to product records.
• Compile, validate, and submit the annual FDA report covering all applicable Coherent products worldwide.
  
  

Environmental Compliance

• Support company-wide compliance with global environmental regulations including:
• RoHS, REACH, WEEE, Waste Framework Directive (WFD), PFAS, Prop 65, TSCA
• Collaborate with third-party service providers to leverage their tools and services for acquiring required documentation and data to support compliance efforts.
• Maintain support and control environmental compliance documentation, such as certificates, product declarations and technical files and ensure files are current, accurate, and complete
• Create and/or revise product content material declarations as needed to support new product development and changes in worldwide environmental regulations
• Develop accurate and timely customer responses to inquiries regarding material contents and compliance for various applicable, world-wide hazardous material regulations
• Partners with internal and external Coherent Corp. suppliers to obtain all required product, sub-assembly, and component material content data, evaluate and interpret content declarations, and conduct confirming analysis and experimentation where needed
  
  

Others

• Customer surveys, compliance entities requests (IntegrityNext, ECO Vadis, etc.)
  
  

Requirements

• Bachelor degree, Material Science, Environmental Engineering or related discipline
• 2-3 years industry experience in RoHS / REACH and related environmental regulations.
• Experience in the computer, telecommunications, optics or similar tech-industries a plus
  
  

Special Skills

• Independent. Able to complete assigned tasks in a timely manner with minimal direction
• Accurate. Excellent attention to detail. Organized
• Proactive. Customer-service focus. A passion for excellence
• Flexible within a dynamic environment. Able to multi-task and reprioritize as needed
• Ownership of an issue or project to resolution. Reliable follow-up and follow-through as needed
• Team Player. Able to collaborate with team members around the world
• Analytical approach to problem solving. Critical thinker. Uses data to substantiate decision making
• Understands the scope and applicability of global environmental directives and regulations
• Strong written and verbal English skills
  
  

Working Conditions

• This role is onsite
  
  

Culture Commitment

Ensure adherence to company’s values (ICARE) in all aspects of your position at Coherent Corp.:

Integrity – Create an Environment of Trust

Collaboration – Innovate Through the Sharing of Ideas

Accountability – Own the Process and the Outcome

Respect – Recognize the Value in Everyone

Enthusiasm – Find a Sense of Purpose in Work

Coherent Corp. is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

About Us

Coherent is a global leader in lasers, engineered materials and networking components. We are a vertically integrated manufacturing company that develops innovative products for diversified applications in the industrial, optical communications, military, life sciences, semiconductor equipment, and consumer markets. Coherent provides a comprehensive career development platform within an environment that challenges employees to perform at their best, while rewarding excellence and hard-work through a competitive compensation program. It's an exciting opportunity to work for a company that offers stability, longevity and growth. Come Join Us!

Note to recruiters and employment agencies: We will not pay for unsolicited resumes from recruiters and employment agencies unless we have a signed agreement and have required assistance, in writing, for a specific opening.

About The Team

Coherent Malaysia (formerly known as II-VI Incorporated) began operations in 2001 through the incorporation of Finisar Malaysia with 300 headcounts, now employs over 3000 employees. Ipoh’s assembly and test site for optical components, transceivers, and wavelength management equipment, remains committed to the expansion of Coherent Corporation, accelerated by the growth of next generation products to meet the increasing demands for network bandwidth and data storage.

Coherent provides a comprehensive career development platform within an environment that challenges employees to perform at their best, while rewarding excellence and hard-work through a competitive compensation program. It's an exciting opportunity to work for a company that offers stability, longevity and growth. Come Join Us!

LinkedIn