Design Quality Post Market Surveillance (Pms) Senior Supervisor

Título del trabajo: Design Quality Post Market Surveillance (Pms) Senior Supervisor

Compañía: Boston Scientific

Descripción de funciones: Additional Locations: N/A Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – High Performance At our company, we value diversity and believe it is our greatest strength.
We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities.
Our belief is that your diversity enriches our work environment.
As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background.
Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.
About the Role: The Post Market Surveillance (PMS) Supervisor will oversee the PMS activities for the DQA Endoscopy division, ensuring compliance with regulatory requirements, internal policies and on time delivery.
This role involves leading a team of professionals, managing cross-functional projects, and serving as a subject matter expert (SME) during audits.
The PMS Supervisor will also be responsible for developing and maintaining tools and processes to analyze and report on product field performance, complaint reduction and fostering a collaborative work environment.
Your Responsibilities Will Include: Supervise and mentor the PMS team, providing guidance and support.
Lead and coordinate complaint reduction and post-marketing projects and initiatives.
Assign resources, manage the cadence, and ensure timely completion of PSURs (Periodic Safety Update Reports) and PMSPs (Post Market Surveillance Plans).
Support internal audit requests and provide necessary documentation and information.
Support the submission of PSURs to regulatory bodies and support any follow-up questions or requests.
Serve as the SME for PMS processes during internal and external audits.
Champion and ensure that Endoscopy practices are in compliance with Global and external standards.
Minimum Qualifications: Bachelor’s degree in engineering, science, or a related field.
Experience: 5 years in similar positions.
English Level desired: Fluent.
Previous experience with Project management.
Strong communication and presentation skills, with the ability to translate performance and issues to various audiences.
Experience working in a regulated environment.
Ability to collaborate and influence across multiple, cross-functional teams.
Demonstrated experience leading projects and coordinating priorities based on business and department objectives.
Preferred Qualifications: Previous experience with Post Market Surveillance activities or related area.
Experience with Quality System Regulations, Medical Device Regulation, and Quality Standards.
Understanding of risk management and familiarity with Post Market requirements Experience working across multiple product areas and cross-functionally Internal Candidates: At least one year in current position.
Performance Evaluation: Successful or above.
Don’t have disciplinary actions in the last 6 months.
Requisition ID: 593545 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life.
Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal.
And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
Benefits • Life-Work Integration • Community • Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level.
With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges.
Together, we’re one global team committed to making a difference in people’s lives around the world.
This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

Ubicación: Cartago

Fecha del trabajo: Mon, 04 Nov 2024 23:07:31 GMT


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