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Quality Compliance Manager, ECMP Site Facilitator

Integra LifeSciences

Mansfield, MA

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JOB DETAILS
SALARY
$109,250–$149,500 Per Year
SKILLS
Change Management, Communication Skills, Cross-Functional, Detail Oriented, Documentation, FDA (Food and Drug Administration), Healthcare, ISO (International Organization for Standardization), Leadership, Maintain Compliance, Medical Equipment, Presentation/Verbal Skills, Problem Solving Skills, Progress Reports, Project Planning, Project Tracking, Project/Program Management, Quality Management, Resume Search, Standards of Care, Team Lead/Manager, Team Player, Willing to Travel
LOCATION
Mansfield, MA
POSTED
30+ days ago
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 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. 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.


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 training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your 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/


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.


This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)


Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.


Unsolicited Agency Submission


Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.


Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)

About the Company

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Integra LifeSciences