Quality Compliance Process Manager Job in New Jersey

Job title: Quality Compliance Process Manager

Company: TMC Compliance

Expected salary:

Location: Somerset, NJ

Quality Compliance Process Manager Job Details:

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

Job Summary

The Quality Compliance Process Manager is responsible for the planning and execution of multiple projects and programs associated with regulation and standard management, as well as sustaining compliance and EU MDR related activities to ensure Terumo Medical Corporation is meeting all medical device and combination medical device/pharmaceutical product requirements. This includes but is not limited to: FDA 21 CFR Part 820, ISO 13485, EU Medical Device Regulation 745/2017, and MDSAP Country requirements. The Quality Compliance Process Manager is accountable for leading and facilitating the activities of the cross-functional project team from Medical Affairs, Post-Market Surveillance, Regulatory Affairs, Risk Management, Sustaining Engineering, NPD, and other applicable teams to achieve the overall attainment of project performance, any related cost-analysis, and schedule objectives. This position does not have direct reports.

Job Details/Responsibilities

Regulations, Standards, EU MDR, and Post-Market Governance Process Management:

• Develop strategic plans for tracking, monitoring, and achieving all deliverables associated with new and revised Documents of External Origin, all required post-market surveillance sustaining activities required to maintain global market access, and all phases of the EU-MDR process.
• Participate in and provide input to TMC Quality strategic planning activities.
• Manage and oversee the execution of projects in accordance with TMC processes and procedures assuring the completion of all project requirements in accordance with them.
• Provide a strong understanding of the needs and business requirements of the area they are managing.
• Lead the cross-functional development of detailed project schedule and resourcing plans to achieve project objectives.
• Implement appropriate advanced project management tools and techniques to drive project execution to include detailed project planning, scheduling, project budgeting, and expense management.
• Interact with Quality Leadership team; conduct 1:1 stakeholder meeting, prepare presentations and formally present project update and reviews.
• Plan and lead cross-functional project team meetings and prepare action items and status updates/minutes for such meetings and reviews.
• Identify potential risks and considerations to the project scope and/or timeline, escalate to management promptly, and make appropriate milestone adjustments.
• Evaluate the progress of all assigned cross-functional activities to ensure the project milestones and deliverables are achieved.
• Provide authoritative advice to all cross-functional parties associated with the program/project.
• Lead special projects as assigned by Quality Leadership.
• Responsible for direct communications with stakeholders to resolve issues, facilitate the gathering of technical information, and provide input on current regulatory requirements.
• Establish and facilitate all Quality Compliance Review Board meetings to ensure all milestones and deliverables are on-track
• Assist with the development, implementation, and maintenance of Quality Performance Indicators for Regulations and Standards management, as well as Post-Market Governance deliverables.
• Work with cross-functional project teams to resolve quality-related issues in a timely and effective manner.
• Perform other duties as assigned.

Knowledge, Skills and Abilities (KSA)

Leadership skills

• Strong and demonstrated understanding of advanced project management tools and techniques to include proficiency in MS Project and simultaneous management of multiple projects.
• Ability to understand regulatory requirements and convert them into relevant business requirements.
• Demonstrated ability to effectively communicate with all levels of the organization including Executive Leadership.
• Strong interpersonal skills to provide clear direction, coaching, training, and mentorship to personnel.
• Capable of influencing across the organization to gain alignment, lead discussions towards decisions, and champion process improvements.

Individual skills

• Effective proofreading and writing skills, as well as exemplary attention to detail.
• Strong organizational and prioritization skills.
• Demonstrated analytical and decision-making skills including the ability to rapidly understand complex changes and pace work completion to the needs of the business.
• Independent decision-making ability on all routine business tasks.
• Proven ability to multi-task and deliver timely results.
• Ability to develop and implement new policies, procedures, strategies, and work processes.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Visio, Project).

Qualifications/ Background Experiences

• B.S. degree in Scientific or Engineering discipline required.
• Minimum of 8 years overall experience in a regulated industry, specifically medical device/diagnostic, pharmaceutical with focus on Quality System Regulations
• Practical experience with FDA, ISO 13485, EU MDR, MDSAP and global quality system requirements, medical device preferred.
• PMP certification preferred.
• Lean Six-Sigma preferred.

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.
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