- 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
- Education:
- Minimum Bachelor's degree in Biomedical Science or a related field.
- 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 2023-3
-
Quality assurance specialist
1 week ago
SilverTech Bridgeport, United StatesWe are looking for a Quality Assurance / Quality Management Specialist (m/f/d) for our client, one of the largest companies for processing of duro and thermoplastics in Europe. · What we offer · Permanent employment in an experienced and motivated team · Competitive salary and ad ...
-
Manager, Quality Assurance
3 weeks ago
Cooper Companies Trumbull, United StatesJob 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 deliverin ...
-
Quality Assurance Coordinator
3 weeks ago
The Cooper Companies Trumbull, United StatesAbout CooperSurgicalCooperSurgical 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 r ...
-
Quality Assurance Coordinator
3 weeks ago
Cooper Companies Trumbull, United StatesJob 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 deliverin ...
-
Quality Assurance Manager
2 weeks ago
Horberg Industries Inc Bridgeport, United StatesJob Description · Job DescriptionJoin Horberg Industries Inc. in Bridgeport, CT as our full-time Quality Assurance Manager and be a key player in maintaining our top-notch manufacturing standards · BECOMING OUR QUALITY ASSURANCE MANAGER · We offer a competitive wage for this posi ...
-
Quality Assurance Coordinator
3 weeks ago
Cooper Companies Trumbull, United StatesJob DescriptionAbout CooperSurgicalCooperSurgical 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 innova ...
-
Quality Assurance Coordinator
4 weeks ago
The Cooper Companies Trumbull, United StatesAbout 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 assiste ...
-
Quality Assurance Specialist
1 week ago
Newtek One Lake Success, United StatesNewtekOne, Your Business Solutions Company, is a financial holding company, which along with its bank and non-bank consolidated subsidiaries, provides a wide range of business and financial solutions under the Newtek brand to the small · - and medium-sized business ("SMB") market ...
-
Quality Assurance Specialist
1 week ago
Newtek One Lake Success, United StatesNewtekOne, Your Business Solutions Company, is a financial holding company, which along with its bank and non-bank consolidated subsidiaries, provides a wide range of business and financial solutions under the Newtek brand to the small · - and medium-sized business ("SMB") market ...
-
Quality Assurance
4 weeks ago
Current USA Smithtown, United StatesDDI's Quality Assurance and Incident Management Associate is responsible for a wide range of tasks within our QA&IM department. Our ideal candidate comes with varied administrative and communication skills.Responsibilities include drafting and editing communications, greeting vis ...
-
Quality Assurance Manager
3 weeks ago
Horberg Industries Inc Bridgeport, United StatesJoin Horberg Industries Inc. in Bridgeport, CT as our full-time Quality Assurance Manager and be a key player in maintaining our top-notch manufacturing standards · BECOMING OUR QUALITY ASSURANCE MANAGER · We offer a competitive wage for this position, along with several outsta ...
-
Quality Assurance Manager
3 weeks ago
Horberg Industries Inc Bridgeport, United StatesJoin Horberg Industries Inc. in Bridgeport, CT as our · full-time Quality Assurance Manager · and be a key player in maintaining our top-notch manufacturing standards · BECOMING OUR QUALITY ASSURANCE MANAGER · We offer a · competitive wage · for this position, along with se ...
-
Quality Assurance Manager
3 weeks ago
Horberg Industries Inc Bridgeport, United StatesJoin Horberg Industries Inc. in Bridgeport, CT as our full-time Quality Assurance Manager and be a key player in maintaining our top-notch manufacturing standardsBECOMING OUR QUALITY ASSURANCE MANAGERWe offer a competitive wage for this position, along with several outstanding be ...
-
Quality Assurance Specialist
1 week ago
Harvard Pilgrim Bridgeport, United StatesHarvard Pilgrim Healthcare · Quality Assurance Specialist - R7659 · Bridgeport , · Connecticut · Apply Now · "Who We ArePoint32Health is a leading health and wellbeing organization, delivering an ever-better personalized health care experience to everyone in our communities. ...
-
Quality Assurance Specialist
2 weeks ago
Internal Revenue Service Bridgeport, United StatesSummary · Click on "Learn more about this agency" button below to view Eligibilities being considered and other IMPORTANT information. · WHERE CAN I FIND OUT MORE ABOUT OTHER IRS CAREERS? Visit us on the web at · This job is open to Career transition (CTAP, ICTAP, RPL) · Fed ...
-
Quality Assurance
3 weeks ago
Adecco Shelton, United StatesJob Description · Job DescriptionAdecco is seeking an experienced Quality Inspector for a top manufacturing company located in Shelton, CT. 1st shift. Pay rate - $20hr · Responsibilities for this Quality Inspector job include: Perform routine in-process inspection tests to ensur ...
-
Quality Assurance Manager
3 weeks ago
Horberg Industries Inc Bridgeport, United StatesJoin Horberg Industries Inc. in Bridgeport, CT as our **full-time Quality Assurance Manager** and be a key player in maintaining our top-notch manufacturing standards · **BECOMING OUR QUALITY ASSURANCE MANAGER** · We offer a **competitive wage** for this position, along with seve ...
-
Quality Assurance Analyst
3 weeks ago
TRESUME Bridgeport, United States**Job Title**: Quality Assurance Analyst · **Job Summary**: · **Responsibilities**: · - Create, execute, and maintain test cases and test scripts based on product requirements and design documents. · - Identify, document, and report software defects and issues using tracking tool ...
-
Director Quality Assurance
3 weeks ago
AGC Acquisition LLC Yalesville, United States Full timeAGC Acquisition LLC and Gar Kenyon Aerospace and Defense are divisions of the LOAR Group co-located in Meriden, Connecticut. The companies are AS9100D certified, FAA MRO certified and NADCAP certified for a variery of OEM and MRO operations. The companies produce a wide variety o ...
-
Quality Assurance Technician
6 days ago
Bunzl Fairfield, United StatesJohn Tillman, a Bunzl company, is lookingfor an ambitious, safety-minded, and detail-oriented QualityAssurance Technician. This position is responsible for performinginspections on incoming parts and materials used in our products,along with utilizing precision measuring instrume ...
Manager, Quality Assurance - Trumbull, United States - The Cooper Companies
Description
About CooperSurgicalCooperSurgical 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 atExperience:
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.#J-18808-Ljbffr
