The
Quality Compliance Manager, ECMP Site Facilitator, provides tactical support and oversight of the implementation of the Enterprise Compliance Master Plan at Integra LifeSciences sites. They are responsible for to developing individual site project plans derived directly from the Enterprise Compliance Master Plan (ECMP), and ensuring that the project plans are being implemented according to the defined timeline and plan. Site Facilitators will work closely with existing site Quality and Operations leaders and may have responsibility for more than one site.
The
Quality Compliance Manager, ECMP Site Facilitator will be traveling between our three (3) sites as needed
(Añasco, Puerto Rico; Mansfield,MA; Cincinnati, OH occasionally) and the established on-site
primary location needs to be Mansfield, MA.Key Responsibilities- Developing and managing sites' project plans for implementation of ECMP workstream outputs;
- Tracking progress and ensuring execution according to plan;
- Reporting sites' progress to ECMP Program Management Office (PMO);
- Being responsible for ECMP documentation and schedule at sites;
- Coordinating collaborative activities between sites' local activities;
- Periodically reviewing the outputs from the sites' work stream activities to ensure it is aligned with requirements of the ECMP and individual site's project plan;
- Facilitating resolution to issues
- Other duties as assigned.
Requirements- Bachelor's degree is required, (Engineering, Science or closely related technical discipline is preferred)
- 10+ years of experience leading a team (indirect reports and/or projects) or equivalent education and years of management experience.
- Experience working Quality Management Systems and understanding compliance.
- Experience in medical device industry required, including material remediation experience.
- Experience in implementing remediation programs, and working with compliance frameworks such as FDA, ISO 13485, and EU MDR.
- Demonstrated management and communication skills. Proven track record of cross-functional collaboration across teams and change management skills.
- Strong attention to detail skills
- Strong communication and presentation skills, with the ability to articulate program status and risks to key stakeholders.
- Ability to travel up to 50% if needed based on site needs. Regular on-site presence at designated facilities within scope of responsibilities.
- Residence requirements: Mansfield, MA
TOOLS AND EQUIPMENT USED
Ability to utilize a computer, telephone, smart phone as well as other general office equipment. Strong computer skills are required.
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 Total Rewards | Integra LifeSciences
