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Open Position, Lewisville, TX

Manager of Regulatory Compliance and Health & Safety

Summary

Compliance Manager for Environment, Health and Safety for the North America Operations of Hoya Corporation. This includes developing, training and monitoring of hazardous chemicals, environmental reporting, project management to increase sustainability and to reduce environmental impact, and requirements for EPA and OSHA regulations. This position is responsible for the regulatory requirements to include HIPAA, FDA, DOT and other regulatory agencies. Position is part of the JSOX and internal audit compliance team and participates in the internal audit functions required under the JSOX guidelines. Manages the Worker Compensation claims and works with the insurance carriers to develop health and safety audits and proactively design programs to reduce injuries and develop good practices. May provide regulatory compliance and health and safety support and oversight to other affiliated divisions in the United States as part of a shared services team as needed. This position will be the main point of contact for the global compliance department (GESH) and be responsible for providing them timely and accurate reporting. Periodic planned travel will be required and estimated to be 8-10 trips per year.

How to Apply

Send cover letter, resume and salary history to hrsandiego@hoyavision.com or fax to (972) 219-8092.

Applicants who are offered a job with HOYA Vision Care will be tested for drugs as part of the post job offer employment screening process.

HOYA is an Equal Opportunity Employer

Health & Safety / Environmental Duties & Responsibilities

Health & Safety

Maintain and provide health and safety requirements according to OSHA and internal SOPs for HVNA to meet regulatory requirements and reduce costs by reducing worker compensation claims and lost time.

Collect injury reporting and analyze any trends to improve health and safety.

Coordinate corrective actions to reduce claims and lost time. Report to GESH corporate health and safety any injuries with lost time over 4 days.

Work with Workers Compensation Insurance Carriers to review and reduce claims throughout the lab network for Worker Compensation. Assist Lab Management and Human Resources on administration of workers compensation claims. Administers claims for the HQ office. Manages Certification requests.

Provide training for the Labs to meet OSHA requirements and conduct periodic audits to ensure compliance. Work with local safety committees to identify areas of risk and ensure SOPs are being followed.

Essential Knowledge of OSHA 29 CFR 1910 requirements.

Environmental Duties & Responsibilities

General knowledge of the requirements of importing chemicals into the United States under the Toxic Substance Control Act. Need to be aware of changes in chemicals and coordinate the communication and sign off of such changes to carriers, purchasing and engineering.

Collect and report data on environmental impact usage of waste, energy and water to Hoya Corporate environmental team. Work with the Regional Vice Presidents to reduce carbon footprint and reduce costs.

Set goals and objectives in regards to reduction in waste, water and energy usage for the top ten laboratories with the operations group. Communicate these goals to GESH and monitor performance at year end.

Audit the hazardous waste disposal to RCRA standards and determine if Pollution Prevention Plans are required.

Approve the usage and engineering controls and PPE required for any new hazardous chemicals

Monitor that Hoya staff handling shipping and receiving of hazardous chemicals have the appropriate certifications and training.

File NPDES applications as needed and audit the labs to determine if exempt facilities meet the requirements for the exemption certification. If a SWPPP is needed implement the plan and audit conformance to the plan.

Understand the Clean Air Act and the requirements for Hoya. In addition, this individual must be knowledgeable of the Clean Water Act and the requirements for CERCLA to ensure compliance.

Apply understanding of the Solid Waste Act to work with waste disposal suppliers and interface with local state, and federal authorities.

General knowledge of the Phase I assessments and facility close down requirements.

Work with suppliers to provide these as required:

California Prop 65 and EPA reporting.

State EPA requirements for generator registration for states with Hoya facility locations.

FDA & HIPAA

FDA Duties and Responsibilities

Knowledgeable in the FDA requirements for 21 CFR 820 GMP(c) for Class I medical devices including the requirements for 21 CFR 801.410.

Be able to use the FURLS FDA system software to maintain the Hoya registrations for US and Foreign Manufacturing facilities.

Perform internal audits to test compliance to the quarterly verification procedures under the drop ball requirements and perform analysis of the results. Work with labs to implement corrective actions where necessary and track corrective actions to ensure compliance to HQ policies and FDA requirements.

Maintain Standard Operating Procedures and files within the document revision process including the standard controls required under 21 CFR 820 for Ophthalmic Lenses.

Knowledge of the FDA product codes for Optical Devices and the requirements and proper registration needed for shipping these medical devices into the US market.

Maintain Standard Operating Procedures and files within the document revision process.

Understand Software validation procedures for any changes to the Spectangle pupillometer device.

Knowledge of California Medical Device licensing process.

HIPAA Duties and Responsibilities

Knowledge of the Health Insurance Portability and Accountability Act and will serve as the related Corporate Compliance Officer.

Verify and complete the processing of Business Associate Agreements.

Audit the labs to verify compliance to HIPAA regulations, security responsibilities and training.

Reporting and notification of Breaches to management should they occur.

Competencies

To perform the job successfully, the individual should have the following competencies:

Problem Solving - Identifies and resolves problems in a timely manner; Uses reason even when dealing with emotional topics.

Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality and professionalism; Keeps emotions under control; Remains open to others' ideas and tries new things.

Communication - Speaks clearly and persuasively in positive or negative situations; Responds well to questions; Participates in meetings. Writes clearly and informatively; Presents numerical data effectively.

Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethics; Upholds organizational values.

Organizational Support - Ability to work effectively with executive management, operations management, and key operations personnel; Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values.

Judgment - Exhibits sound and accurate judgment; Includes appropriate people in decision-making process.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently.

Attendance/Punctuality - Is consistently at work and on time. Ability to work overtime as needed.

Other Qualifications

Foreign Export Procedures

Be able to complete and check export information and documentation to meet the requirements of the US Department of Commerce and WMD tracking requirements for Japan.

Trademarks and Patents
Able to understand the trademark process and supply information to all team members as to the status of the filings, the due dates for submissions, in addition to providing support materials and communicating any conflicts.

Obtain approval signatures required for filing.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Education and/or Experience

Preferred to have a Bachelor’s Degree in Safety Health and Environmental or comparable experience.

5 years minimum experience. May substitute combination of education and experience.

Computer Skills

Working knowledge of current Microsoft operating software and office suites including Access.

Certificates, Licenses, Registrations

CSP preferred not required.

Must have an acceptable Motor Vehicle Record (MVR) per Hoya’s MVR policy as driving is an essential job function.

Not Exclusive

The duties outlined in this document are not limited to what is presented and are not exclusive. You may be asked from time to time to perform additional duties by your supervisor