Sr. Quality Compliance Engineer

Job Summary

The Senior Quality Compliance Engineer will work with the Senior Manager of Quality Compliance to ensure Terumo Medical Corporation is achieving compliance to all global regulations and external standards for medical devices, combination medical device/pharmaceutical, and software products through collaborative partnerships and out-reach with cross-functional departments. This includes but is not limited to: FDA 21 CFR Part 820, ISO 13485, EU Medical Device Regulation 745/2017, and MDSAP Country requirements.

Job Details/Responsibilities

• Ensure TMC is effectively monitoring for all new and revised external regulations and standards.

• Partner with Quality Compliance Process Manager to establish time-bound product plans to conduct gap assessments and remediation activities within the required timeframes.

• Provide Regulation and Standard Management assistance to the organization as required.

• Assist management on development, implementation, and maintenance of Quality Performance Indicators for Standards management and dashboard to monitor product/process compliance to the most up-to-date requirements.

• Collaborate with Post-Market Surveillance team to establish a robust process for overseeing the management of all post-market sustaining activities required to maintain global market access.

• Monitor to ensure input from cross-functional teams required for PMSP, PSUR, PMCF, CEP, and CERs is being provided in accordance with the established schedule.

• Escalate issues impacting the timeliness of the post-market requirements and external standard deliverables to management.

• Coach, mentor, and cross-train less experienced staff on the skills and competency required to successfully perform their responsibilities.

• Support TMC sites and subsidiaries on compliance and quality related issues.

• Participate on product design teams and verify compliance to applicable regulations and external standards.

• Coordinate input from various stakeholders, such as Medical Affairs and PMS, required to draft Health Hazards Evaluations and ensure information provided to the Critical Action Committee meeting is complete and accurate.

• Partner with cross-functional teams on projects (NPD, Sustaining, Acquisition) as a Compliance SME, including the role of:

• Independent reviewer on design control projects to ensure compliance with internal regulations and external standards.

• Drive Quality System or product enhancement projects associated with regulatory changes.

• Review and draft proposed changes to Quality System procedures/forms as required to maintain compliance and improve overall efficiency and effectiveness.

• Perform other job-related tasks as assigned.

Knowledge, Skills and Abilities (KSA)

• Practical experience with FDA, ISO 13485, EU MDR, MDSAP and global quality system requirements, preferably for medical devices.

• Solid analytical and critical thinking skills.

• Demonstrated ability to effectively communicate with all levels of the organization including Executive Leadership.

• Ability to provide clear direction to others.

• Strong interpersonal skills with the capability to influence cross functional collaboration.

• Effective proofreading and writing skills.

• Strong organizational and prioritization skills.

• Ability to navigate the grey.

• Demonstrated decision-making skills including the ability to rapidly understand complex changes and pace work completion to the needs of the company.

• Independent decision-making on routine business tasks.

• Proven ability to multi-task and deliver timely results.

• Proficient computer knowledge (MS Office)

• Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.

Qualifications/ Background Experiences

• B.S. degree or equivalent in Scientific or Engineering discipline required.

• Master's degree in science or engineering preferred.

• Minimum of 5 to 8 years overall experience in a regulated industry, specifically medical device/diagnostic, pharmaceutical with focus on Quality System Regulations