Quality Assurance Coordinator - Healthcare jobs in Simi Valley, CA

ABOUT HEALTHCARE COMPONENTS GROUP

Healthcare Components Group is dedicated to the design, manufacturing, and supply of quality components and solutions for the healthcare industry. With almost 100 years of combined expertise serving our industry, we are proud of the excellent global reputation for quality and customer service that we have earned.

OUR IDEAL CANDIDATE

Our ideal candidate would have at least 2 years of experience in Quality Control or Quality Assurance with familiarity in both. This person should have an associate degree in a technical discipline or a high school diploma with an equivalent work experience; typically 7 years of related experience with increasing responsibility.

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:

The QA/QC Supervisor is responsible for providing oversight of the Quality Management System and conducting work tasks related to QC inspection and testing of incoming, in-process and finished items. This individual is responsible for overseeing of the day-to-day Quality activities at the Simi Valley, CA location.

Essential Duties & Responsibilities:

• Develop, plan and implement process improvements to the Quality Management System
• Maintain the Quality Management System in accordance to ISO 9001 and US FDA 820 standards.
• Conduct Internal Audits per annual schedule.
• Coordinate external audits and inspections from Notified Bodies, Regulatory Agencies and Customers.
• Facilitate Management Review.
• Record, disposition, and investigate Customer Complaint (Return Material Authorization) in a timely manner.
• Conduct investigations and CAPA investigations as needed.
• Perform receiving, in-process and final inspections and record inspection data as required.
• Package products per instructions after inspection is complete.
• Comply with applicable Quality Management System requirements, including Quality Policy, Quality Manual, QMS Procedures, Work Instructions, Forms, Recordkeeping, etc.
• Participate in cross-training to improve ongoing efficiency and business continuity.
• Maintain a clean and orderly work environment.
• Work closely with other departments
• Perform other tasks as deemed necessary by Director of Quality

ADDITIONAL EXPERIENCE/SKILL/EDUCATIONAL REQUIREMENTS:

The ideal candidate for this role will have the following qualifications:

• Typing and 10-key
• Proficient with Microsoft Office Suite
• Excellent Communication Skills, both written and verbal
• Follows written and verbal directions with limited oversight
• Effectively communicates, reads and writes in English language
• Able to multi-task with frequent interruptions in a fast-paced environment
• Able to interpret QC technical drawings and diagrams
• Proficiency with basic computer usage, including Microsoft Office required
• Willingness to work on interdepartmental assignments as required

BENEFITS OF WORKING AT HCG

• Begin your journey to a healthier future with enrollment in medical, dental, vision, disability, and life insurance, starting the first of the month after date of hire.
• Secure your financial well-being with a 401k enrollment accompanied by an employer match after 30 days of employment.
• Enjoy competitive PTO accrual and a well-deserved Holiday schedule, ensuring work-life balance.
• Enjoy work in a friendly, team oriented environment

WORKING CONDITIONS

The job is performed at our facilities in a climate controlled non-smoking environment. It requires a person to work day shift and overtime as peak workload may require.

PHYSICAL REQUIREMENTS

The job requires standing and sitting for extended lengths of time and the ability to lift and manage packages and products weighing up to 30 lbs.