Quality Assurance Auditor
New World Medical is a growing medical device company based in Rancho Cucamonga. We were founded with the mission of benefiting humanity. Our firm works to live up to this lofty goal by developing, manufacturing, and marketing cutting-edge medical devices intended to alleviate the suffering of glaucoma patients globally.
Our mission is to preserve and enhance vision by delivering innovations to Benefit Humanity through safe and effective medical devices. We commit to our company-wide core values:
INTEGRITY ~ ACCOUNTABILITY ~ INNOVATION
The Quality Assurance Auditor administrates regulatory compliance activities related to NWM’s Internal and External Audit Program. This position’s key functions relate to the facilitation and execution of internal inspection process, management of the Internal Audit Program at New World Medical to identify Quality System improvements, management of suppliers and conducts supplier audits as needed to assess compliance to all applicable Standards, Regulations, and New World Medical Quality System Requirements.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
- Schedules, manages and conducts audits of New World Medical activities to assess compliance to all applicable Standards, Regulations, and New World Medical Requirements.
- Participate in External Quality Audits as a process subject matter expert.
- Identifies compliance risks to current standards / regulations and assist in the planning and execution of Quality System improvements to mitigate those risks.
- Responsible for supporting Development, Engineering and Manufacturing to resolve technical issues and implement corrective and preventive action.
- Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams including NWM and suppliers.
- Leads the qualification and maintenance process for suppliers, including initial and routine supplier evaluation and audits as required.
- Works with suppliers and New World Medical’s Sustaining and Production Department to establish, maintain, and assess associated risks of their controlled manufacturing processes.
- Build and maintain relationships with suppliers to establish and verify/audit control methods suitable to the nature of the parts they supply and ensure clear communication of New World requirements to all levels of manufacturing.
- Work with suppliers on establishing robust validated measurement methodologies.
- Responsible for reporting of quality trends and information to management on the performance of suppliers.
- Demonstrated ability to lead, acknowledge, develop, communicate & implement strategies for developing new supplier, including qualification.
- Work with suppliers to establish a structured approach for consistency and adherence to quality procedures and requirements.
- Work Closely with QA team to manage suppliers to ensure product quality.
- Follow up with non-conformances during in-process inspection, pre-shipment inspection, quality complaints from internal customers, product returns and safety recalls. Identify / drive root cause analysis, corrective action and preventive action implementation.
- Expected travel for this position is approximately 25%-40%.
KNOWLEDGE, SKILLS AND ABILITIES:
- Must have good communication skills.
- Candidate must be able to work autonomously and independently.
- Candidate must have high energy and lots of stamina. Must be a team player and have a strong work ethic.
EDUCATION AND EXPERIENCE:
- Bachelor's degree in engineering and minimum 5-year experience in medical device industry is required.
- Direct experience with supplier producing product and parts in a regulatory environment (i.e. GMPs, ISO13485, 21 CFR Part 820, etc.) preferred.
- Must have knowledge of Quality Engineering discipline, including statistics.
- Strong working knowledge of DMAIC/Six Sigma problem solving process. Belt certified a big plus.
- Competent in Process Audit, CAPA, PPAP, Equipment Validation.
Certified Auditor Qualification or equivalent is required.
New World Medical, Inc. (NWM) is an Equal Opportunity Employer. NWM takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.