Quality Specialist II (Complaints Investigations)

Cork - Ireland

Monthly Salary: Not Disclosed

Posted on: Yesterday

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 II on a permanent basis to join our team.

Job Purpose

The Complaints Investigator Approver will work closely with the Complaints Investigator to review and approve all complaints related to pharmaceutical products. This role also involves reviewing complaint metrics and trends collaborating with the Pharmacovigilance team and preparing metrics for management review. The successful candidate will ensure compliance with regulatory requirements and maintain high standards of documentation and accuracy.

Key Responsibilities

Review and approve all complaints investigated by the Complaints Investigator.
Ensure complaint investigations meet regulatory and internal quality standards.
Review complaint metrics and identify trends for continuous improvement.
Collaborate with the Pharmacovigilance team to ensure accurate reporting and compliance.
Prepare and present complaint metrics for management review and quality meetings.
Support audits and inspections by providing approved complaint documentation.
Participate in training programmes including an initial 1012 week period in Farnham UK.
Maintain up-to-date knowledge of pharmaceutical quality systems and regulatory requirements.
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 Degree in a technical scientific or quality discipline.
Minimum 5 years experience in a pharmaceutical quality compliance or complaints management role.
Proven experience in reviewing and approving complaint investigations within a regulated environment.
High attention to detail and excellent documentation skills.
Strong analytical problem-solving and organisational abilities.
Proficient in Microsoft Office applications and electronic quality management systems (e.g. MasterControl).
Excellent written and verbal communication skills.
Ability to work independently and as part of a cross-functional team.
Willingness to travel for initial training in Farnham UK (1012 weeks).
Commitment to maintaining confidentiality and compliance with company and regulatory standards
Experience with complaint trending and metric analysis.
Familiarity with HPRA FDA and other regulatory agency requirements.
Previous experience presenting complaint metrics during audits or management reviews.

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...