Performance Health and Wellness, headquartered in Warrenville, Illinois, is the maker of clinically-proven brands sold across the globe in a wide range of channels, including retail, specialty retail, professional and e-commerce. We are a growing company providing solutions for health and wellness, exercise and performance, rehab and recovery, and pain relief. Our products and content empower people in every stage of an active life—from injury recovery all the way to performing at an elite level. Our mission motivates our performance every day. Around the world, we serve consumers, athletes, patients, and healthcare practitioners with proven solutions to common needs and problems. These leverage effective and innovative products backed by clinical research, empowering education, instructions and content, endorsement by healthcare professionals, and practice-building support.
Performance Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, and any other characteristic protected by law.
Our Akron, OH team is seeking a quality system professional that will serve as the Quality System Analyst. This position supports the Quality System Manager and team and includes various activities such as metric and status reporting, analysis of quality system data, system administration for quality system software programs, over sight of document control activities and projects, assist with creating and implementing compliant quality system procedures for medical device, OCT drug and Cosmetic products per FDA and ISO requirements. This position will also oversee the internal audit program and candidate will perform internal audits as well as assist with 3rd party quality system and regulatory audits.
To perform this job successfully, an individual must be able to perform each essential job duties satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Essential Job Duties & Responsibilities
Responsible for development and issuance of all quality metric reports and trending analysis
Quality Management software system administration
Supports and monitors Document Control processing of all new controlled documents and requests for changes to documentation within the electronic document system
Oversee Internal Audit Program and participates as lead auditor for internal audits and participate in 3rd party quality system and regulatory audits
Develops, documents and implements quality system standard operating procedures
Participate in cross-functional NPD, integration and other key initiatives/projects
Assist with software validation
Bachelor degree or equivalent; or four years related experience and/or training; or equivalent combination of education and experience
Strong understanding of ISO, FDA and International quality system and regulatory
Individual should have knowledge of MSWord word processing software; Excel spreadsheet software; Access database software; MSPowerpoint. ERP and Quality System software awareness helpful.
About Performance Health
Performance Health and Wellness is the maker of clinically-proven brands sold across the globe in a wide range of channels, including retail, specialty retail, professional and e-commerce. We are a growing company providing solutions for health and wellness, exercise and performance, rehab and recovery, and pain relief.