What are the responsibilities and job description for the Quality Associate - 2nd Shift - 4 days working (On Agency Payroll) position at American Surgical Company?
Under general guidance, this individual will be responsible for compliance of American Surgical Company's quality system with 21 CFR Part 820, ISO 13485, ISO 14971, 93/42/EEC (Medical Devices Directive) and Canadian Medical Devices Regulations. Knowledge of FDA regulations and national and international standards including but not limited to 21 Part 820, ISO 13485, ISO 14971, Council Directive 93/42/EEC (Medical Devices Directive) and Canadian Medical Devices Regulations at an intermediate level is expected.
Routine Duties and Functions (may include but are not limited to the following):
- Perform incoming inspection of raw material, in-progress inspection of open work orders and final inspection of finished product using company approved procedures and equipment
- Record and investigate non-conformances and product complaints, determine root
- cause and implement corrective/preventive actions
- Perform incoming inspection using ANSI/ASQ Z1.4 2008 sampling plan
- Inspect kitted material for new work orders issued to Manufacturing
- Review and final approve Manufacturing lot history records and file lots
- Label product with Approved, Reject, or Quarantine label stickers
- Monitor temperature and humidity in controlled areas
- Create product pouch template labels/finished product box labels using company approved procedures and equipment
- Issue internal lot numbers for incoming raw material, and finished product
Special skills / requirements:
- Data driven
- Team Player
- Positive mental attitude
- Ability and willingness to learn new skills including Lean Six Sigma
- Coordinate multiple projects
- Ability to perform detail-oriented work
- Ability to handle multiple tasks in a timely fashion
- Ability to track open items and follow-up
- Presentation skills to share information in small groups with employees and management
- Adapt to a flexible environment with changing daily workload priorities as directed
- Fluent in English (Spanish preferred)
- Proficient in Microsoft Office; strong computer skills are essential for this role
Education / Experience:
- High school diploma required and demonstration of ability and willingness to learn.
Pay: $20.00 - $25.00 per hour
Expected hours: 40.0 per week
Work Location: In person
Salary : $20 - $25