Quality Compliance Specialist - Oral Care

Location:

Grand Rapids, MI, US, 49512

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview

The Quality Compliance Specialist is responsible for ensuring compliance with regulatory requirements and internal quality standards while supporting post-market surveillance activities. This role focuses on reviewing and analyzing product complaints to monitor product safety and performance across medical devices, pharmaceutical, and cosmetic products.

Scope of the Role

Act as a Liaison for the insourced Complaint Handling system. Review complaint reports from various sources for different products.
Support Medical Device Reporting (MDR) evaluations
Support CAPA administrative activities
Participate in internal and external audits/inspections, including preparation and on-site support.
Serve as scribe during external audits
Assist with coordination of internal audits and GMP floor audits
Escalate issues to Senior Compliance Specialist or Management
Support administrative tasks for QMS meetings and documentation
Follow GMP requirements
Support continuous improvement initiatives to enhance product quality and compliance.
Perform basic data analysis, including statistical trending using Excel charts/graphs.
Learn Perrigo products, becoming knowledgeable on product failure modes and performance issues.
Identify unique situations, high-risk complaints, or increasing trends and escalate to management.
Work and communicate with a variety of different functional groups
Support effective implementation of all GMP requirements and understand how it affects products/processes supported and/or owned.

Experience Required

Bachelor’s degree in technical disciplines such as Engineering, or Science preferred.
Minimum of 1+ years of experience in medical device industry or pharmaceutical environment.
Proficient in the English language.
Work well with peers and management in a team environment and as an individual contributor.
Good verbal and written communication skills.
Proficient in Microsoft Office and TrackWise
Ability to perform basic data analysis, charting and graphing in Excel.
Understand and carry out oral instructions.
Read, understand, and interpret manuals and written instructions.
Self-motivated, with excellent attention to detail.

Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here

Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) All application materials, including resumes and CVs, must be submitted in English. Thank you.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo