Works closely with Department Managers in prioritizing timely completion of product QC problem-solving issues regulatory affairs etc. Trains new and existing personnel on OSHA and FDA guidelines and the ISO quality management system.
Summary of Essential Job Duties: An individual must be able to successfully perform the essential functions of this position with or without a reasonable accommodation.
- Primary responsibility will be to coordinate implement and assist in the activities of the Quality Control Department
- Implementing and maintaining the DHRs in the quality system
- Must work with all aspects of regulatory affairs (FDA OSHA MDR TGA ROHS REACH PPE others as applicable) and help the organization make appropriate decisions regarding regulatory affairs
- Works to ensure process and procedures are controlled accurate in reflecting the current process and meet expectations as defined ISO policy
- Assist in Quality Management System audits internal external customer and supplier audits
- Will be responsible for assisting in coordinating corrective/preventive actions continual improvement customer complaints and nonconformances and investigating root cause and effectiveness of actions taken
- Participates in the External Audits for ISO Certification and other certification organizations
- Reports out on ISO findings; reviews ISO corrective actions/preventative actions (CAPAs)
- Evaluates and analyzes the efforts in organizing documenting and interpreting inspection support documents and records
- Working with Product Development/Management associates contractors and outsourcing firms to develop product requirements
- Assist in conducting quarterly management meetings and prepare reports
- Keeps up on standards regulations/laws issues and news with respect to product (service) quality
- Additional duties as assigned
Skills/Qualifications: To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Excellent organizational and follow-up skills
- Detailed oriented individual with high energy level
- Strong problem solving and analytical skill sets
- Ability to conceptualize interactions of process with regards to integrating for a effective and efficient quality management system as it relates to the organizations goals
- Self-motivated with a strong sense of urgency
- Excellent communication skills oral and written
- Ability to multi-task organize and prioritize ongoing projects
- Ability to treat confidential information with sensitivity
- Must be assertive objective and participate and able to work with all levels of Associates
- Must be flexible with work schedule
- Must be able to travel
- Strong leadership skills with the ability to drive the continual improvement process within the organization
- Strong commitment to quality
- Microsoft Suite advanced skills in Excel
- Ability to work in a fast pace environment
Education Certificates Licenses Registrations:
- BS/BA in Business Administration Quality Control Engineer
- 5 or more years experience QC/QMS/ISO/Regulatory experience
Additional Information :
All your information will be kept confidential according to EEOC guidelines.
Remote Work :
No
Employment Type :
Full-time
Works closely with Department Managers in prioritizing timely completion of product QC problem-solving issues regulatory affairs etc. Trains new and existing personnel on OSHA and FDA guidelines and the ISO quality management system. Summary of Essential Job Duties: An individual must be able to su...
Works closely with Department Managers in prioritizing timely completion of product QC problem-solving issues regulatory affairs etc. Trains new and existing personnel on OSHA and FDA guidelines and the ISO quality management system.
Summary of Essential Job Duties: An individual must be able to successfully perform the essential functions of this position with or without a reasonable accommodation.
- Primary responsibility will be to coordinate implement and assist in the activities of the Quality Control Department
- Implementing and maintaining the DHRs in the quality system
- Must work with all aspects of regulatory affairs (FDA OSHA MDR TGA ROHS REACH PPE others as applicable) and help the organization make appropriate decisions regarding regulatory affairs
- Works to ensure process and procedures are controlled accurate in reflecting the current process and meet expectations as defined ISO policy
- Assist in Quality Management System audits internal external customer and supplier audits
- Will be responsible for assisting in coordinating corrective/preventive actions continual improvement customer complaints and nonconformances and investigating root cause and effectiveness of actions taken
- Participates in the External Audits for ISO Certification and other certification organizations
- Reports out on ISO findings; reviews ISO corrective actions/preventative actions (CAPAs)
- Evaluates and analyzes the efforts in organizing documenting and interpreting inspection support documents and records
- Working with Product Development/Management associates contractors and outsourcing firms to develop product requirements
- Assist in conducting quarterly management meetings and prepare reports
- Keeps up on standards regulations/laws issues and news with respect to product (service) quality
- Additional duties as assigned
Skills/Qualifications: To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Excellent organizational and follow-up skills
- Detailed oriented individual with high energy level
- Strong problem solving and analytical skill sets
- Ability to conceptualize interactions of process with regards to integrating for a effective and efficient quality management system as it relates to the organizations goals
- Self-motivated with a strong sense of urgency
- Excellent communication skills oral and written
- Ability to multi-task organize and prioritize ongoing projects
- Ability to treat confidential information with sensitivity
- Must be assertive objective and participate and able to work with all levels of Associates
- Must be flexible with work schedule
- Must be able to travel
- Strong leadership skills with the ability to drive the continual improvement process within the organization
- Strong commitment to quality
- Microsoft Suite advanced skills in Excel
- Ability to work in a fast pace environment
Education Certificates Licenses Registrations:
- BS/BA in Business Administration Quality Control Engineer
- 5 or more years experience QC/QMS/ISO/Regulatory experience
Additional Information :
All your information will be kept confidential according to EEOC guidelines.
Remote Work :
No
Employment Type :
Full-time
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