Staff Quality Engineer, Change Control ECMP Workstream Leader

About the role

The Staff Quality Engineer, ECMP Work stream Leader plays a critical role within the Enterprise Compliance Master Plan (ECMP) team. This role leads the Change Control Work stream, focusing on lifecycle management for product changes and document controls for the Quality Management System (QMS).

Responsibilities

• Drive standardization and deploy world-class solutions to improve quality and compliance.
• Evaluate new regulations, guidelines, and industry standards and implement plans to maintain compliance across the business.
• Establish a global community of practice for the designated QMS area, enhancing governance and oversight to ensure compliance and consistency in relevant sub-processes.
• Collaborate with process owners and stakeholders 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.
• Influence and collaborate across stakeholder groups to identify and implement opportunities for process/system improvements.
• Drive quality culture improvements and foster collaboration to ensure functional teams work harmoniously and secure synergy and strengths across global teams.
• Provide 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.
• Demonstrate technical leadership as an inter-departmental resource, coaching and teaching other Integra Leaders across all functions and geographies.
• Perform other related duties as expected.

Qualifications

• Bachelor’s Degree in Engineering, 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.

Physical Requirements

The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of the position to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Additional Information

This position could require up to 50% travel.

Pay Range

$109,250.00 - $149,500.00 USD

Schedule

Not specified

Benefits

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences:

• Medical
• Dental
• Vision
• Life Insurance
• Short- and Long-Term Disability
• Business Accident Insurance
• Group Legal Insurance
• Savings Plan (401(k))

Equal Opportunity Employer

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.