Quality Technician

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

About us:

Join a company where the work you do makes a difference!  We are One Team with One Goal.  At STERIS Applied Sterilization Technologies (AST), it’s our philosophy and our way of doing business.  Through a network of over 50 facilities globally, STERIS AST has been committed to providing contract sterilization services to the medical device, pharmaceutical, consumer, and industrial communities for over 40 years.  Our sterilization services ensure the safety of those who use these products, including our families, our friends, and ourselves.

Assists Quality System/Regulatory Compliance (QS/RC) and Analyst(s) to ensure external and internal Customer requirements are met according to documented and communicated policies and procedures.

The Quality Technician is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. The Quality Technician supports production and quality operations by assisting in performing and documenting problem solving investigations, conducting pre-reviews of Customer product and run set-up and final acceptance/run release through review of run records/device history records. 

Quality Technicians assist in identifying, documenting and investigating non-conformances, Customer complaints, CAPAs and internal/external audit findings.  They work with operations and quality team members to perform and document problem-solving investigations and continuous improvement initiatives.  In addition, to performing run releases, Quality Technicians may execute review of calibration and operating logs.

What you will do with us:

• Conducts pre-review on incoming product to confirm compliance to the Customer’s processing specifications, verifies calculations, correct dose range, approved product codes, dosimeter placements and special instructions. 
• Releases processing runs after product has been processed, ensuring all processing parameters and Customer specifications have been met and the run file (device history record) is accurate and complete.
• Assists in Quality investigations, associated problem-solving activities and continuous improvement initiatives. 
• Identifies, documents and investigates non-conformances to establish sustainable corrective actions.  Supports investigations into Customer complaints and internal/external audit observations. 

What you will do with us - cont'd:

• Assist in the development (and revisions to) quality system policies and procedures.
• Executes review of operating logs (i.e. spectrophotometer, pre-conditioning, aeration), preventive maintenance schedules, maintenance work orders, and site calibration activities to ensure timely and accurate recordkeeping.  Responsible to escalate matters of non-compliance to site Quality Lead/Manager.   
• Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations. 
• Complete other duties as assigned.

How you will learn your role:

• Review work instructions along with vital policies and procedures
• Take part in on-the-job training, overseen by your Hiring Manager
• Demonstrate ability to meet the requirements of the job

Education Degree

• Associate's Degree in Engineering General or Science

You will be a great fit if you can:

• Ability to work in a fast-paced, regulated environment with strict deadlines
• Mathematical skills including ratios, proportions, basic algebra
• Ability to generate detailed, high quality documentation. 
• Ability to work with others in analyzing and solving technical problems.
• Teamwork: Collaborates with others. Works in a professional manner to support team actions. 
• Effectively manages work tasks.  Is detail oriented and strives for continuous improvement.
• Above average organizational skills
• PC experience and working familiarity of common desktop applications including Excel and Word.

• Possess a Minimum of one (1) year of experience in a manufacturing or processing environment or other technical/scientific field. 4+ years relevant technical/scientific experience with a high school diploma in lieu of an Associate Degree will be accepted.

Reasons you'll love working here:

This is an opportunity to join a company that will invest in you for the long-term. STERIS wouldn’t be where it is today without our incredible pe