Manager, Quality Assurance - Trumbull, United States - Cooper Companies

Cooper Companies Trumbull, United States

3 weeks ago

Description

Job Description

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.

CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families.

We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO).

CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians.

More information can be found at

Responsibilities

The Post Market Surveillance, Corrections & Removals Manager monitors and coordinates Correction & Removal programs for medical products and includes activities such as preparation of required documentation (e.g. Health Hazard Evaluation, Field Strategy, Field Safety Communications, Regulatory Monitoring Reports, and Termination Requests.)
Providing oversight of the corrections and removal process. Assuring standard processes and procedures exists. Overseeing the development Health Hazard Evaluations (HHE) and ensuring proper documentation and alignment

Collaborating with leadership within Quality and Medical Affairs on the development and approval of the Health Hazard Evaluation that may lead to Field Action.

Providing oversight of the execution of product recalls with Customers, Dealers, and regional regulatory representatives; Communicating with the FDA and other regulators regarding field actions, as needed; Leading the corrections and removal process for the designated business units
Assessing and identifying process improvements, developing and implementing business solutions related to correction and removal processes; Collaborating with leaders across Business Units, Markets, and functions to ensure procedures and processes are compliant to all applicable regulations
Manage, develop, and mentor department personnel.
Leads a team of cross functional Post Market professionals through the process of HHE and C&R activities
Manage progress of Health Hazard Evaluations from initiation through completion, ensuring swift and thorough completion
Manage and oversee the Health Hazard Evaluation risk assessment
Coordinates Advisory Board Meetings including scheduling, presentations, and meeting outcomes

Primary contact for CooperSurgical, liaising with business units and markets to develop C&R strategy, initiate C&R, resolve regulatory agency requests in relation to reportable C&R and ensure timely closure and termination of C&R activities.

Lead all field action reporting activities and engagement with competent authorities while assuring correctness and consistency of the Field Safety Notices (FSN) /Customer Information Letter (CIL) content

Leads C&R Strategy meetings, promptly identifying potential reportable and safety related C&R, ensuring timely notification to regulators and affected customers.

Escalates and reports out progress to CSI leadership on HHEs and C&Rs as appropriate and required per local QMS procedures
Ensure reporting requirements are compliant with CSI Policy in accordance with applicable laws and regulations worldwide.
Establish and maintain department metrics that compliment CSI goals, targets, and objectives.
Develop an atmosphere to encourage, motivate, and promote growth opportunity.
Oversee, support, and maintain compliance with disposition and reporting activities world-wide
Maintains active communication with Authorized Representative(s), and Notified Body as required.
Stay apprised of latest developments in the regulatory landscape related to Post Market Surveillance
Maintain Quality Management System procedures related to applicable Post Market Vigilance activities

Qualifications

Education:
Minimum Bachelor's degree in Biomedical Science or a related field.

Experience:
Minimum 5 years of Risk Management experience
Minimum 5 years of Quality Management Systems experience
Project Manager experience a plus
CAPA Management lead/owner experience a plus
Prior experience working within a global organization/team
Related experience in Correction & Removal processes, regulatory submissions, Risk Management, and/or project management preferred within the medical device or similar industry

An ideal candidate will come from a direct correction and removal role within the medical device industry having worked with software.

Strong analytical skills
Ability to communicate with various stakeholders both verbally and in writing
Ability to balance multiple projects/tasks, with a high degree of initiative
Flexibility to adapt to an everchanging environment
Excellent verbal and written communication skills.
Strong presentation skills.
Solid understanding of the Quality Management System and the associated interrelationships
Knowledge of FDA regulations 21 CFR 803, 805, 806, 820 and ISO standards 13485, 14971, and EU MDR 2017/745 and MDCG

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan.

As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.

Please visit us at to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies:
Please, no phone calls or emails to any employee of CooperSurgical about this opening.

All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place.

In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status.

We are proud to be an equal opportunity workplace.
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