Junior Regulatory Specialist at TE Connectivity
Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Andover, Minnesota
TE Connectivity Ltd., is a $13 billion global technology and manufacturing leader creating a safer, sustainable, productive, and connected future. For more than 75 years, our connectivity and sensor solutions, proven in the harshest environments, have enabled advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With 78,000 employees, including more than 7,000 engineers, working alongside customers in nearly 150 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.
TE is now one of the largest sensor companies in the world, with innovative sensor solutions that help customers transform concepts into smart, connected creations. TE s unmatched portfolio of intelligent, efficient and high-performing sensor solutions are used for customers across several industries, from automotive, industrial and commercial transportation and aerospace and defense, to medical solutions and consumer applications.
TE Connectivity's Quality Assurance position is responsible for assisting quality with Quality System support by assisting in management of CAPAs, RMAs, Management Review, audits, regulatory submissions and aiding in monitoring the effectiveness of the quality system.This position is responsible for assisting quality with Quality System support by assisting in management of CAPAs, RMAs, Management Review, audits, regulatory submissions and aiding in monitoring the effectiveness of the quality system.
RESPONSIBILITIES & QUALIFICATIONS
* FDA, NB, Third Party audit coordination and support
* Internal auditor
* Quality reporting and Management review prep
* Medical CAPA, CCAR, RMA assistance, notifications, and trending
* Quality System Trending support
* Post market Surveillance support
* MDR vigilance reporting support
* Establishment registration
* Product listing
* Labeling support
* Regulatory submission support
* Front room scribe (for FDA)
* Standards upkeep and yearly revision audit
* Adhere to stated policies and procedures relating to health and safety, and quality management i.e. ISO and Corporate.
* Other duties as assigned by manager
* 2-year degree preferred
* 1-3 years' experience in Medical Industry
* Must be US person or PRC holder due to access to products and technology controlled under the ITAR & EAR.
* This individual must be self-driven, results-oriented with a positive outlook and a clear focus on quality.
* Comfortable in dealing with employees at all levels. Good communicator and customer friendly.
* Must be proficient in use of MS Office Excel, Word, Access, and PowerPoint.
* Good communication and computer skills, including data analysis and report writing skills
* Basic computer skills - Keyboarding, Word, data entry.
* Values: Integrity, Accountability,Teamwork, Innovation
As an Equal Opportunity Employer, TE Connectivity does not discriminate because of Race, Religion, Color, Age, Gender, Marital Status, Sexual Orientation, Gender Identity, National Origin, Physical or Mental Disability, or Protected Veteran Status, or any other categories protected by law.
Individuals with disabilities, who require a reasonable accommodation to complete this application and/or to participate in any part of the employee selection process, should contact us via e-mail at CorporateStaffing@TE.com or by phone (610) 893-9333.