Director Quality Systems and Compliance

We are flexible with location - Somerset, NJ; Elkton, MD; or Caguas, Puerto Rico

Job Summary :

The Director, Quality Systems and Compliance is responsible for the design, development, deployment, and maintenance of the company’s Quality System.

This individual the primary interface with external regulatory agencies for audits and is responsible for ensuring our Quality System is continually compliant will all applicable regulations and standards including but not limited to : U.

S. Quality System Regulation, Japanese Pharmaceutical Affairs Laws, ISO 13485, the Canadian Quality System Regulation, the European Union Medical Device Regulation (EU MDR), etc.

Job Details :

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Support the development of a proactive and preventive quality systems culture throughout the business.

Manage and develop a team of quality systems and compliance managers. Establish a high-performing team to drive the organizational goals & objectives and instill quality culture.

Drive engagement to ensure personnel have clear expectations, appropriate tools and information, an opportunity to share, grow and develop and are recognized for their contributions.

• Develop, support, maintain, and continuously improve the TMC Quality system in accordance with applicable regulations for a global medical device corporation including, but not limited to, 21 CFR 820, ISO 13485 : 2016, EU Medical Device Regulation, and MDSAP.
• Ensure appropriate management oversight by organizing the Quality System Management Review and other key quality system governance boards.

Develop and maintain dashboard of Quality System Performance measures. Drive the escalation of emerging signals into the company’s corrective and preventive action process (CAPA).

• Manage Quality System audits with Regulatory Agencies and Notified Bodies. Ensure appropriate action and follow-up for open action items and / or effectiveness checks for items are addressed in a timely manner.
• Along with the VP, Quality serve as a primary interface with the Terumo Corporation office of the Chief Quality Officer (CQO).

Ensure all CQO commitments are addressed in a complete and timely manner.

Develop a learning culture throughout the organization. In conjunction with functional SMEs, develop effective, compliant, and engaging training material to meet global regulations.

Improve training processes to ensure accurate role-based training.

Oversee the quality change management process in alignment with the global regulations. Ensure all product and process changes are appropriately evaluated for impact by a cross-functional team.

Implement process improvements to facilitate compliance and business efficiency.

Direct the company’s post-market surveillance program, ensuring on time adverse event reporting, trending, and corrective actions.

Manage product recalls to ensure compliance with applicable global regulations. Maintain compliance to the post-market deliverables of EU MDR.

Support TMC sites and subsidiaries on compliance and quality system related challenges. Work with site personnel to identify root cause and corrective action plans to improve the quality system.

Drive corrective actions across the organization.

• Follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.
• Perform other duties as assigned.

Position Requirements :

Knowledge, Skills and Abilities (KSAs)

Quality and business process knowledge :

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

Strong analytical skills including trend and statistical analysis.

Ability to use process development tools (ex. Lean Six Sigma)

Leadership Skills :

Demonstrated ability to communicate and interact with all levels of the organization including Executive Leadership.

• Strong interpersonal skills to provide coaching, training, and direction.
• Demonstrated ability to provide clear direction and mentor personnel.
• Proven experience influencing across the organization to improve product or processes.

Individual skills required :

• Strong proofreading and writing skills, as well as exemplary attention to detail
• Demonstrated organizational and prioritization skills
• Exceptional decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company.
• Demonstrated initiative and ability to work independently while handling multiple tasks
• Strong computer knowledge (MS Office), technical writing skills and proofreading ability
• Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.

Background Experiences

• Requires a four-year degree in a technical / science / engineering field.
• Minimum 10 years' overall experience with at least 5 years of related experience in medical devices / diagnostics, pharmaceutical or other regulated industry required with a focus on quality systems.
• A minimum of 5 years in a supervisory / management role.
10 days ago