Staff Quality Engineer, ECMP Workstream Leader

Integra LifeSciences•Mansfield, MA

6d•$109,250 - $149,500

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Staff Quality Engineer, ECMP Workstream Leader is a key role within the Enterprise Compliance Master Plan (ECMP), having the responsibility to design, implement, and oversee quality and compliance improvement and remediation strategies for a designated area (or areas) of the Quality Management System (QMS). This role will be responsible for leading a team of individuals and partnering with global quality leaders to develop processes that result in attaining the company’s improvement objectives and growth strategies across more than 15 design, manufacturing, and distribution facilities and a diverse portfolio of leading medical devices. This role is crucial for ensuring the development, manufacture, and distribution of medical devices in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical Affairs Law, and other applicable regulatory agencies.

Requirements

Bachelor’s Degree in Engineering, or Sciences or relevant Technical Field required. Master’s degree preferred.
Minimum 10 years of experience in quality, manufacturing, or engineering, or equivalent education and years of experience
Strong experience leading deployment of enterprise quality management solutions
Experience in FDA controlled environment.
Strong collaboration and facilitation skills and experience working in a matrix environment.
Ability to interface with technical and non-technical personnel.
Knowledge of FDA QMSR, ISO, MDSAP, EU MDR, PMD Act and other applicable standards and regulations.
This position could require up to 50% travel.

Nice To Haves

Master’s degree preferred.

Responsibilities

Drive standardization & deploy world-class solutions to drive improved quality and compliance.
Recognized as a leading expert and internal thought leader in the designated QMS area with high-level knowledge and broad, comprehensive knowledge of other QMS disciplines.
Leads major improvements to existing processes and develops or champions new systems, concepts, and procedures to solve unique and complex problems that have a broad impact on the business.
Evaluate new regulations, guidelines and industry standards and their impact on ECMP QMS Workstream processes; plan and effectively implement plans across the business to maintain compliance.
Establish a global community of practice for the designated QMS area or collaborate with responsible people to enhance the existing community of practice, including governance and oversight, to ensure compliance and consistency in relevant sub-processes applicable to the designated QMS area.
Collaborate with process owners and stakeholders in corporate, divisions and sites to ensure the program is compliant, executable, and meets user needs.
Ensure compliance of all process and digital improvements with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, EU MDR and PMD Act.
Interact and coordinate activities with other departments, external vendors, and customers.
Influences and collaborates across stakeholder groups in the areas of process / system improvements, identify and implement opportunities.
- Drive quality culture improvements and foster collaboration to ensure functional teams work harmoniously and secure synergy and strengths across the global teams.
Provides strategic direction and communication of the ECMP QMS work stream goals, directives, and policies to employees, creating a clear vision and positive, team-oriented environment resulting in the achievement of the company’s goals and increased profitability.
Demonstrates technical leadership as an inter-departmental resource coaching and teaching other Integra Leaders across all functions and geographies.
Perform other related duties as expected.