ISO Compliance Manager

Position Title: ISO Compliance Manager

Office Location: Georgia

Job Summary: The ISO Compliance Manager will maintain the company’s Quality Management System (QMS) in compliance with ISO 13485, EU Medical Regulation (MDR), and Medical Device Single Audit Program (MDSAP) certifications. This role will assist with the development, publishing, and implementation of company policies and procedures to support the continual improvement of our Quality System and maintain accredited registration in the certifications standards as it is built to support the responsible recycling initiatives. Maintain policies and procedures relative to the scope of the management system along with creating and documenting new policies/procedures with video training guides and training in collaboration with all employees. The scope includes all departments in the organization. Establish quality, environmental, health, and safety objectives. Target and monitor these targets as well as monitoring of key processes and develop metrics to report to the Leadership team.

Key Responsibilities

• Communicate the importance of the Environmental, Health and Safety Management System

• Identify environmental, health, and safety aspects of products, activities, and services

• Ensuring that the processes and EH&SMS are established, implemented, and maintained in accordance with the requirements of these Standards: ISO 13485, EU Medical Regulation (MDR), and Medical Device Single Audit Program (MDSAP).

• Responsible for coordinating regulatory programs and the applications and helping support the compliance process; supporting and providing compliance with all the environmental issues and identifying the context of our organization and determining the interested parties that may influence the EHS system.

• Review accidents and incidents which occur in the area of responsibility and conduct audits.

• Maintain working relationships with Regulatory Agencies and lead the Safety Committee Meetings for our operations.

• Ensuring the promotion of awareness of customer requirements throughout the organization.

• Practice safe working techniques and re-enforce the safety policies, guidelines, and procedures as set out by the Company.

• Maintain and update as needed all procedures and work instructions for all safe work practices and equipment and utilize them in the day-to-day training.

• Ensure regulatory agencies’ inspections are coordinated and deficiencies minimized and corrected.

• Communicate with management on facility deficiencies and monthly safety inspections.

• Accountable for researching and writing permit applications and working with environmental consultants and being compliant in completing permit reporting requirements if necessary.

• Maintain all logs and documentation associated with permits and regulatory requirements.

• Provide daily guidance and direction in EHS programs at the employee/supervisor level to ensure a common and effective approach.

• Responsible for assisting in the identification of possible losses; evaluating the risk in such loss exposure; developing and implementing a plan to correct or prevent a loss and auditing the plan to ensure its effectiveness

• Responsible for document management to ensure processes, documentation, JESs (Job Element Sheets) that are part of the company’s QMS are regularly updated for accuracy and suitability.

Qualifications:

• Working knowledge of ISO 13485, EU Medical Regulation (MDR), and Medical Device Single Audit Program (MDSAP) certifications.

• Minimum of five years’ experience in Environmental Health and Safety/ISO Quality Compliance role.

• Have completed the OSHA 30-hour training course.

• Understanding of Internal Auditing, including Root Cause Analysis.

• Strong organizational and planning skills.

• Strong work ethic with follow up and follow through.

• Flexible to change and open to constructive feedback.

• Strong decision-making and problem-solving skills. Ability to anticipate/identify problems and recommend appropriate solutions.

• Advanced computer skills (e.g. MS Office including Excel and Word) are essential.

• Detail-oriented, able to analyze data and procedures.

• Creative – ability to use the data at hand to derive new meaningful metrics.

• Knowledgeable and familiar with general Warehouse processes.

• Knowledgeable and familiar with general Production processes.

• Project Manager certification preferred.

AAP/EEO Statement

phasetwo is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees and complying with all related employment regulatory requirements. We do not discriminate in employment-related decisions on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or another non-merit factor.

phasetwo is an EEO/AA Employer M/F/D/V.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without warning.

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