Regulatory Specialist at TE Connectivity
Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Andover, Minnesota
TE Connectivity (NYSE: TEL) is a $14 billion global technology leader. Our connectivity and sensor solutions are essential in today s increasingly connected world. We collaborate with engineers to transform their concepts into creations redefining what s possible using intelligent, efficient and high-performing TE products and solutions proven in harsh environments. Our 80,000 people, including 7,500 design engineers, partner with customers in over 150 countries across a wide range of industries. We believe EVERY CONNECTION COUNTS www.TE.com.
With the recent acquisition of Measurement Specialties, a global designer and manufacturer of sensors and sensor-based systems, TE offers an unmatched range of both connectivity and sensor solutions. Sensor solutions include a rich portfolio of temperature, humidity, pressure and piezoelectric film technologies for a wide range of applications. We are at the heart of many everyday products and provide a vital link to the physical world. More detailed company information is available at our web site: www.meas-spec.com.
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.