Quality Technician II

The Role

Completes assigned Quality tasks to include process, software, and test method validations; product testing; sterilization validations and routine testing, calibration, as well as other support duties described below.

Responsibilities

• Captures process and sterilization validation/QE Test activities with production, warehouse, and Quality Assurance.
• Performs and documents product testing in support of validations and QE Tests.
• Aids Quality Engineer in preparing protocols and summaries for Validation and QE tests as needed.
• Collaborates with other teammates to support validation activities.
• Sets up quotes and generates purchase requisitions for third-party dose audit testing program.
• Prepares dunnage and production product for use in EO Sterilization Validation loads.
• Manages calibration system and coordinates calibration requests with appropriate teammates.
• Secures quotes, generates purchase requisitions, and ships/facilitates test equipment requiring external calibration.
• Manages air and temperature monitoring systems.
• Manages material stored in QE Test location.
• Supports and maintains productions process control equipment.
• Provides input to Quality Engineer regarding validation, calibration, and testing plans.
• Performs additional duties as directed.

Requirements

Associate's degree or equivalent from two-year college or technical school; or six months to one-year related experience and/or training; or equivalent combination of education and experience.

Qualifications

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Knowledge of FDA quality system requirements.
• Works independently as a self-starter committed to delivering the highest in customer service, quality and results.

Skills

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

Benefits

Comprehensive Healthcare Plan - Medical, dental, and vision plans start on day one of employment for full-time teammates.
Educational Assistance - We offer educational assistance to all eligible teammates enrolled in an approved, accredited collegiate program.
Employer-Paid Life Insurance and Disability - We offer employer-paid life insurance and disability coverage.
Voluntary Supplemental Programs – We offer additional options to secure your financial future including supplemental life, hospitalization, critical illness, and other insurance programs.
Paid Leave - In addition to sick days and short-term leave, we offer holidays, vacation days, personal days, and additional types of leave – including parental leave.
Well-Being – Also included in our offering is a Teammate Assistance Program (TAP), Calm Health, Cancer Resources Services, and discount programs – all at no cost to you.

Pay

The anticipated pay range for this position is $20 to $25/h. The actual compensation offered may vary based on job related factors such as experience, skills, education and location.