TieTalent
3 days ago Be among the first 25 applicants
*Labeling Engineer*
*Hybrid- Santa Clara, CA*
The Labeling Engineer completes all work related to the creation of new labeling, updates, or changes to labeling content (labels, IFU, Implant Cards, etc.) following the document change control process established at Shockwave and ensures is carried out in compliance with Shockwave’s labeling procedures. The Labeling Engineer works collaboratively with Regulatory to remain in compliance with the global labeling standards and regulations for the medical device industry and coordinates implementation of labeling changes into production with all impacted stakeholders.
*Essential Job Functions *
Support labeling activities for new products, commercial products, clinical builds from initiation to implementation Work collaboratively with Regulatory Affairs to create new labels and determine labeling content based on procedures, standards, and regulations. Manage the labeling change process from initiation to implementation to meet established timelines and negotiate exceptions to plan Perform labeling project updates to impacted stakeholders and maintain a communication channel throughout all the phases of the project Coordinate with the labeling designer/technician during artwork development and work collaboratively to resolve any issues related to label scripting/coding/symbols Develop and maintain documentation for labeling content and label creation. Create and manage change requests within the document control system. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Perform other related duties and responsibilities, on occasion, as assigned. Ability to learn and support systems integration projects like PLM, ERP, MES
*Requirements *
Bachelor’s degree in engineering or engineering discipline (Biomedical, Industrial, etc). Knowledge of PLM, ERP, and or MES is preferred but not required. Minimum of three (3) years of relevant experience in labeling for the medical device industry. Knowledge of compliance with applicable Quality System requirements such as QSRs, FDA, ISO 11607, MDR, MDSAP and other applicable regulations related to labeling. Knowledge of documentation management and understanding of Good Manufacturing Practices (GMPs). Ability to use labeling design software. Ability to work in a fast-paced environment while managing multiple priorities.
_Brooksource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws._
Job Type: Contract
Pay: $55.00 - $65.00 per hour
Benefits:
Dental insurance Health insurance Vision insurance
Work Location: Hybrid remote in Santa Clara, CA 95054 Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
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*Hybrid- Santa Clara, CA*
The Labeling Engineer completes all work related to the creation of new labeling, updates, or changes to labeling content (labels, IFU, Implant Cards, etc.) following the document change control process established at Shockwave and ensures is carried out in compliance with Shockwave’s labeling procedures. The Labeling Engineer works collaboratively with Regulatory to remain in compliance with the global labeling standards and regulations for the medical device industry and coordinates implementation of labeling changes into production with all impacted stakeholders.
*Essential Job Functions *
Support labeling activities for new products, commercial products, clinical builds from initiation to implementation Work collaboratively with Regulatory Affairs to create new labels and determine labeling content based on procedures, standards, and regulations. Manage the labeling change process from initiation to implementation to meet established timelines and negotiate exceptions to plan Perform labeling project updates to impacted stakeholders and maintain a communication channel throughout all the phases of the project Coordinate with the labeling designer/technician during artwork development and work collaboratively to resolve any issues related to label scripting/coding/symbols Develop and maintain documentation for labeling content and label creation. Create and manage change requests within the document control system. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Perform other related duties and responsibilities, on occasion, as assigned. Ability to learn and support systems integration projects like PLM, ERP, MES
*Requirements *
Bachelor’s degree in engineering or engineering discipline (Biomedical, Industrial, etc). Knowledge of PLM, ERP, and or MES is preferred but not required. Minimum of three (3) years of relevant experience in labeling for the medical device industry. Knowledge of compliance with applicable Quality System requirements such as QSRs, FDA, ISO 11607, MDR, MDSAP and other applicable regulations related to labeling. Knowledge of documentation management and understanding of Good Manufacturing Practices (GMPs). Ability to use labeling design software. Ability to work in a fast-paced environment while managing multiple priorities.
_Brooksource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws._
Job Type: Contract
Pay: $55.00 - $65.00 per hour
Benefits:
Dental insurance Health insurance Vision insurance
Work Location: Hybrid remote in Santa Clara, CA 95054 Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Other Industries Technology, Information and Internet Referrals increase your chances of interviewing at TieTalent by 2x Get notified about new Specialist jobs in
Santa Clara, CA . Fremont, CA $95,000.00-$143,000.00 1 week ago Executive Assistant to VPs of Product Management
San Jose, CA $101,000.00-$112,000.00 3 days ago Palo Alto, CA $168,000.00-$179,000.00 2 weeks ago San Jose, CA $128,000.00-$240,667.00 1 week ago Sunnyvale, CA $114,000.00-$163,000.00 2 weeks ago Pleasanton, CA $62,700.00-$81,500.00 1 week ago Business Intelligence Analyst, Growth Marketing
Sunnyvale, CA $114,000.00-$163,000.00 3 days ago San Jose, CA $76,500.00-$126,500.00 1 month ago San Jose, CA $60,000.00-$65,000.00 1 year ago San Jose, CA $88,000.00-$151,112.00 5 days ago Dublin, CA $77,900.00-$117,050.00 1 day ago Palo Alto, CA $50,000.00-$60,000.00 1 month ago Palo Alto, CA $70,000.00-$85,000.00 2 weeks ago Creator & User Excellence Specialist - Customer Support - San Jose
San Jose, CA $110,223.00-$198,445.00 5 days ago Fremont, CA $31,000.00-$121,000.00 9 months ago Mountain View, CA $60,000.00-$80,000.00 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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