What are the responsibilities and job description for the Assistant Quality Manager position at Element2 Group?
A leading manufacturing facility in Bristol, RI, is seeking a full-time Assistant Quality Manager to oversee and administer the company’s quality system in accordance with ISO 9001, 13485:2016, and MDR standards. This role is responsible for establishing procedures to maintain high standards of quality and safety, ensuring compliance across operations, and working closely with customers and vendors on quality-related matters.
Key Responsibilities:
- Administer and maintain the company’s quality system to meet ISO 9001, 13485:2016, and MDR requirements.
- Ensure all SOPs, work instructions, and drawings comply with ISO 9001 and 13485 standards.
- Collaborate with internal teams, customers, and vendors to resolve quality-related issues.
- Lead CAPA (Corrective and Preventative Action) initiatives and problem reports.
- Implement quality control procedures and support continuous improvement efforts.
Qualifications:
-3 years of experience in quality control documentation.
-Direct experience working within ISO 9001 and 13485 standards.
-Strong knowledge of CAPA processes and problem-solving methodologies.
-Familiarity with Medical Device Regulations (MDR).
-General knowledge of machine tools, assembly techniques, and computer systems.
Job Type: Full-time
Pay: $29.00 - $31.00 per hour
Expected hours: 40 per week
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Work Location: In person
Salary : $29 - $31
