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Posted : Thursday, August 29, 2024 02:50 AM
We are seeking someone who's work experience has been specialized within the Technical and Regulatory field, specifically in the medical device industry; ISO 13845 experience is a MUST and 510K experience is a PLUS.
*About CC Wellness:* CC Wellness is a rapidly growing California-based pharmaceutical company focused on delivering personal care and intimate wellness products in a socially responsible manner through science-based innovation and world-class manufacturing.
Even the smallest choices in life can lead to big changes.
Like a ripple resonating from a single raindrop, the impact you make today can transform someone’s wellbeing tomorrow.
Come join us and make waves together! *Summary: *The Quality System Supervisor ensures compliance of the Quality Management System in accordance with applicable compliance standards and guidelines.
The Quality System Supervisor works collaboratively with personnel from other functional areas by providing process leadership for the development, maintenance, and continuous improvement of Quality System programs and processes throughout.
This includes, but is not limited to, Internal and External Audits, Regulatory Filing and Certifications, Regulatory Compliance activities, Change Control, Training, Document Control, Record Retention, Product and Customer Complaints Handling, and CAPA Program, which includes the Deviations, Corrective Action, and Preventive Action.
*Essential Duties and Responsibilities: *To perform this job successfully, an individual must be able to perform the following satisfactorily; other duties may be assigned.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Supports the development, maintenance, and continuous improvement of quality programs, processes, and procedures as needed.
* Supports the Regulatory team with 510k submission efforts as well as communications with FDA/Regulatory bodies, as applicable.
* Ensures Quality System policies, procedures, and performance conform to regulatory requirements, standards, and guidelines.
* Supports Quality System process performance and improvements; including, but not limited to, Management Review, Change Control, Internal Audits, Training, Document Control, Record Retention, Product and Customer Complaints Handling, Deviation reporting and investigations, Corrective Action and Preventive Action (CAPA).
* Works directly with suppliers and customers to ensure quality system requirements are met as needed.
* Performs internal audits and inspections, including writing of audit reports and presenting to upper management.
Responsible for adherence to audit timelines and reporting.
* Assists with external audits of suppliers, as needed.
* Responsible for coordinating customer and regulatory audits and inspections, including audit/inspection response and tracking.
* Support the Regulatory team with compliance activities, as needed.
* Prepares and presents quality system performance reports for management, as needed.
* May assist in other Quality or Regulatory related functions, as needed.
*Skills and Qualifications:* *Education/Experience:* * Bachelor’s degree in a technical or scientific discipline, and at least one year related experience and or training, or an equivalent combination of education and experience.
*Computer Skills:* * Microsoft Office Teams Word, Excel (Intermediate to Advanced), PowerPoint, Internet Explorer * NetSuite experience preferred (ERP experience required) *Competencies: * * Knowledge and experience with FDA certifications is a Plus.
* Knowledge and experience with ISO certifications is a Plus.
* ERP experience required.
* Bilingual a plus – English & Spanish, fluent in speaking, writing and reading in both languages * Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.
* Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
* Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
*Physical Demands:* The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Speaking and engaging frequently, possibly before large groups or on cell phones * Standing, walking and moving for long periods in multiple environments and temperatures * Computer work with laptops and monitors * Some local travel needed to additional locations for meetings and events.
*Language Ability:* The ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
You will need to write routine reports and correspondence.
You need the ability to speak effectively before groups of customers or employees of the organization.
Fluency to speak Spanish is preferred.
CC Wellness is an equal opportunity employer of protected veterans and individuals with disabilities.
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of disability or their protected veteran status.
COVID Vaccine requirement is a condition of employment, reasonable accommodations will be considered for those who qualify.
Job Type: Full-time Pay: $75,000.
00 - $95,000.
00 per year Benefits: * 401(k) * Dental insurance * Employee assistance program * Flexible schedule * Flexible spending account * Health insurance * Health savings account * Life insurance * Paid time off * Vision insurance Schedule: * 8 hour shift * Day shift * Monday to Friday * Overtime * Weekends as needed Education: * Bachelor's (Required) Language: * Spanish (Preferred) Ability to Commute: * Valencia, CA 91355 (Required) Ability to Relocate: * Valencia, CA 91355: Relocate before starting work (Required) Work Location: In person
*About CC Wellness:* CC Wellness is a rapidly growing California-based pharmaceutical company focused on delivering personal care and intimate wellness products in a socially responsible manner through science-based innovation and world-class manufacturing.
Even the smallest choices in life can lead to big changes.
Like a ripple resonating from a single raindrop, the impact you make today can transform someone’s wellbeing tomorrow.
Come join us and make waves together! *Summary: *The Quality System Supervisor ensures compliance of the Quality Management System in accordance with applicable compliance standards and guidelines.
The Quality System Supervisor works collaboratively with personnel from other functional areas by providing process leadership for the development, maintenance, and continuous improvement of Quality System programs and processes throughout.
This includes, but is not limited to, Internal and External Audits, Regulatory Filing and Certifications, Regulatory Compliance activities, Change Control, Training, Document Control, Record Retention, Product and Customer Complaints Handling, and CAPA Program, which includes the Deviations, Corrective Action, and Preventive Action.
*Essential Duties and Responsibilities: *To perform this job successfully, an individual must be able to perform the following satisfactorily; other duties may be assigned.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Supports the development, maintenance, and continuous improvement of quality programs, processes, and procedures as needed.
* Supports the Regulatory team with 510k submission efforts as well as communications with FDA/Regulatory bodies, as applicable.
* Ensures Quality System policies, procedures, and performance conform to regulatory requirements, standards, and guidelines.
* Supports Quality System process performance and improvements; including, but not limited to, Management Review, Change Control, Internal Audits, Training, Document Control, Record Retention, Product and Customer Complaints Handling, Deviation reporting and investigations, Corrective Action and Preventive Action (CAPA).
* Works directly with suppliers and customers to ensure quality system requirements are met as needed.
* Performs internal audits and inspections, including writing of audit reports and presenting to upper management.
Responsible for adherence to audit timelines and reporting.
* Assists with external audits of suppliers, as needed.
* Responsible for coordinating customer and regulatory audits and inspections, including audit/inspection response and tracking.
* Support the Regulatory team with compliance activities, as needed.
* Prepares and presents quality system performance reports for management, as needed.
* May assist in other Quality or Regulatory related functions, as needed.
*Skills and Qualifications:* *Education/Experience:* * Bachelor’s degree in a technical or scientific discipline, and at least one year related experience and or training, or an equivalent combination of education and experience.
*Computer Skills:* * Microsoft Office Teams Word, Excel (Intermediate to Advanced), PowerPoint, Internet Explorer * NetSuite experience preferred (ERP experience required) *Competencies: * * Knowledge and experience with FDA certifications is a Plus.
* Knowledge and experience with ISO certifications is a Plus.
* ERP experience required.
* Bilingual a plus – English & Spanish, fluent in speaking, writing and reading in both languages * Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.
* Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
* Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
*Physical Demands:* The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Speaking and engaging frequently, possibly before large groups or on cell phones * Standing, walking and moving for long periods in multiple environments and temperatures * Computer work with laptops and monitors * Some local travel needed to additional locations for meetings and events.
*Language Ability:* The ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
You will need to write routine reports and correspondence.
You need the ability to speak effectively before groups of customers or employees of the organization.
Fluency to speak Spanish is preferred.
CC Wellness is an equal opportunity employer of protected veterans and individuals with disabilities.
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of disability or their protected veteran status.
COVID Vaccine requirement is a condition of employment, reasonable accommodations will be considered for those who qualify.
Job Type: Full-time Pay: $75,000.
00 - $95,000.
00 per year Benefits: * 401(k) * Dental insurance * Employee assistance program * Flexible schedule * Flexible spending account * Health insurance * Health savings account * Life insurance * Paid time off * Vision insurance Schedule: * 8 hour shift * Day shift * Monday to Friday * Overtime * Weekends as needed Education: * Bachelor's (Required) Language: * Spanish (Preferred) Ability to Commute: * Valencia, CA 91355 (Required) Ability to Relocate: * Valencia, CA 91355: Relocate before starting work (Required) Work Location: In person
• Phone : NA
• Location : 29000 Hancock Pkwy, Valencia, CA
• Post ID: 9148164252
