Quality Specialist I (Complaints Investigations)

Cork - Ireland

Monthly Salary: Not Disclosed

Posted on: 21 hours ago

Vacancies: 1 Vacancy

Job Summary

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

Advancing possibilities for a brighter tomorrow

We are seeking a Quality Specialist I on a permanent basis to join our team.

Job Purpose:

The Complaints Investigator will be responsible for investigating customer complaints related to pharmaceutical products ensuring thorough documentation of findings within MasterControl. The role requires high attention to detail excellent documentation skills and the ability to work independently and collaboratively across teams. The successful candidate will support the maintenance of quality standards and regulatory compliance contributing to continuous improvement in complaint handling processes.

Key Responsibilities

Investigate and document customer complaints for pharmaceutical products to a high standard within MasterControl.
Conduct root cause analysis and risk assessments as part of complaint investigations.
Collaborate with cross-functional teams (Quality Assurance Pharmacovigilance Regulatory Operations and Technical Team) to resolve product issues and support process improvements.
Ensure compliance with relevant cGxP regulatory requirements and internal procedures.
Prepare clear accurate and timely investigation reports and maintain complete records of all complaint activities.
Present findings and compliant processes during internal and external audits.
Participate in training programs including an initial 1012 week period in Farnham UK.
Support continuous improvement initiatives in complaint handling and documentation.
Maintain up-to-date knowledge of pharmaceutical quality systems regulatory requirements and industry trends.
Support the Pharmaceutical Quality System team initiatives and activities
Initiates and writes/updates required procedures to support activities.
Identifies deviations from standard practices evaluates their impact and determines corrective actions.

Requirements

Level 8 Honours Bachelor Degree in Quality or related discipline.
3 years experience working in Pharmaceutical industry (Ideally in a QA role)
Excellent understanding and hands-on working knowledge of cGMP quality and regulatory requirements.
Previous experience in a Quality or Manufacturing background particularly in relation to pharmaceutical quality systems
Strong communication skills both verbal and written with good interpersonal skills.
Skilled in using Microsoft Office applications.
Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems.
Working knowledge and understanding of FDA HPRA and the pharmaceutical industry quality requirements and associated with manufacturing controls desirable
Experience in problem solving and process improvement methodologiesdesirable
Post Market Complaint investigation and CAPA experience desirable

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 isnt just business its personal. And if youre 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!

To search and apply for open positions visit: Boston Scientific we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion equality and opportunity for all. By embracing the richness of our unique backgrounds and perspectives we create a better more rewarding place for our employees to work and reflect the patients customers and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process please email

Required Experience:

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling some of the most important health industry challenges. Wi...