CooperSurgical
CooperSurgical, a division of CooperCompanies, 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.
Our mission is to enable patients to experience life’s beautiful moments through a range of products from contraception to assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.
Responsibilities
Partner with senior management and site management to facilitate post‑market surveillance across all locations.
Drive quality improvement activities and LEAN principles within the organization.
Serve as the Cooper Surgical expert on post‑market surveillance activities, ensuring sites are supported through decision‑making, closure, and termination of issues.
Establish robust and consistent evaluation methodology ensuring adverse event reporting is applied consistently across all Cooper Surgical sites.
Function as the subject matter expert on post‑market surveillance matters, including during external audits/inspections by regulatory authorities (e.g., Notified Bodies, FDA).
Drive continuous improvement and LEAN activities with sites to improve efficiencies in post‑market activities.
Champion IT projects impacting post‑market functions and/or systems.
Conduct periodic post‑market surveillance review meetings to provide senior management with information regarding complaints and feedback.
Oversee the complaint management team ensuring all feedback mechanisms are captured and addressed timely.
Design, establish, implement, and maintain a resource plan that fully supports business needs to capture post‑market feedback.
Ensure appropriate company‑wide training for employees on reporting customer complaints.
Lead strategic planning, direction, and goal setting for the department or function.
Instill a culture of continuous improvement by developing and implementing strategies that achieve measurable results.
Manage a team of direct reports and provide guidance, coaching, evaluation and hiring of quality personnel as needed.
Perform other duties as assigned.
Travel This position may require 10‑15% domestic and/or foreign travel.
Qualifications
Extensive knowledge of ISO 13485, FDA CFR 820, FDA CFR 806, FDA CFR 803, pharmacovigilance and emerging standards and regulations related to post‑market and vigilance activities.
Ability to work in a matrixed organization and develop strong relationships at all levels, partnering across multidisciplinary teams.
Excellent situational analysis and judgment, able to provide guidance and counsel to site and staff throughout the organization.
Strong time‑management skills as an individual contributor and as a leader, driving projects to scheduled completion on time.
Excellent team‑building and leadership skills, able to motivate team members to drive projects to successful conclusion, with the ability to manage and lead without direct authority.
Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).
Strong data‑analysis, negotiation, and problem‑solving skills.
Experience
10+ years total experience in the medical device industry.
5+ years of experience managing Quality Assurance in the medical device industry.
Experience in Post‑Market Surveillance.
Experience with MS Word, Excel, Project Management and Analytics software.
Experience liaising with multiple international regulatory bodies and managing cross‑cultural teams.
Education
Bachelor’s degree in Health or Engineering field required; advanced degree preferred.
Professional affiliations in Quality Management preferred; required licenses, if any, must be maintained and periodically renewed as needed.
Work Environment
Prolonged periods of sitting, especially in front of a computer.
Potential exposure to different manufacturing environments, necessitating adherence to varying safety protocols.
Benefits As an employee of CooperSurgical, you’ll receive an outstanding total compensation plan. We offer a comprehensive benefits package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks.
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. If you require special assistance or accommodations due to a disability, please contact talent.acquisition@coopersurgical.com.
#J-18808-Ljbffr
Our mission is to enable patients to experience life’s beautiful moments through a range of products from contraception to assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.
Responsibilities
Partner with senior management and site management to facilitate post‑market surveillance across all locations.
Drive quality improvement activities and LEAN principles within the organization.
Serve as the Cooper Surgical expert on post‑market surveillance activities, ensuring sites are supported through decision‑making, closure, and termination of issues.
Establish robust and consistent evaluation methodology ensuring adverse event reporting is applied consistently across all Cooper Surgical sites.
Function as the subject matter expert on post‑market surveillance matters, including during external audits/inspections by regulatory authorities (e.g., Notified Bodies, FDA).
Drive continuous improvement and LEAN activities with sites to improve efficiencies in post‑market activities.
Champion IT projects impacting post‑market functions and/or systems.
Conduct periodic post‑market surveillance review meetings to provide senior management with information regarding complaints and feedback.
Oversee the complaint management team ensuring all feedback mechanisms are captured and addressed timely.
Design, establish, implement, and maintain a resource plan that fully supports business needs to capture post‑market feedback.
Ensure appropriate company‑wide training for employees on reporting customer complaints.
Lead strategic planning, direction, and goal setting for the department or function.
Instill a culture of continuous improvement by developing and implementing strategies that achieve measurable results.
Manage a team of direct reports and provide guidance, coaching, evaluation and hiring of quality personnel as needed.
Perform other duties as assigned.
Travel This position may require 10‑15% domestic and/or foreign travel.
Qualifications
Extensive knowledge of ISO 13485, FDA CFR 820, FDA CFR 806, FDA CFR 803, pharmacovigilance and emerging standards and regulations related to post‑market and vigilance activities.
Ability to work in a matrixed organization and develop strong relationships at all levels, partnering across multidisciplinary teams.
Excellent situational analysis and judgment, able to provide guidance and counsel to site and staff throughout the organization.
Strong time‑management skills as an individual contributor and as a leader, driving projects to scheduled completion on time.
Excellent team‑building and leadership skills, able to motivate team members to drive projects to successful conclusion, with the ability to manage and lead without direct authority.
Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).
Strong data‑analysis, negotiation, and problem‑solving skills.
Experience
10+ years total experience in the medical device industry.
5+ years of experience managing Quality Assurance in the medical device industry.
Experience in Post‑Market Surveillance.
Experience with MS Word, Excel, Project Management and Analytics software.
Experience liaising with multiple international regulatory bodies and managing cross‑cultural teams.
Education
Bachelor’s degree in Health or Engineering field required; advanced degree preferred.
Professional affiliations in Quality Management preferred; required licenses, if any, must be maintained and periodically renewed as needed.
Work Environment
Prolonged periods of sitting, especially in front of a computer.
Potential exposure to different manufacturing environments, necessitating adherence to varying safety protocols.
Benefits As an employee of CooperSurgical, you’ll receive an outstanding total compensation plan. We offer a comprehensive benefits package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks.
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. If you require special assistance or accommodations due to a disability, please contact talent.acquisition@coopersurgical.com.
#J-18808-Ljbffr