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.

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.

QUALIFICATIONS:

• 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.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position.

ADVERSE WORKING CONDITIONS

There are no adverse working conditions associated with this position.

Salary Pay Range:

$109,250.00 - $149,500.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour recruiter can share more about the specific salary range for your preferred location during the hiring process.

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)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/