Quality Analyst Bardi

Quality Analyst
Bardi
Emilia Romagna, Bardi

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.

**Position Summary**:

This position is responsible for assisting in administration of the quality functions at the site in accordance with the requirements for ISO, FDA QSR, and STERIS policies.

This would include but is not limited to: review quality records (i. e.

Device History Records), inspection, complaint investigation, record management, data trending, and document control functions.

**Duties**:

Responsible for the following:

- Document Control transactions in change control management system.

- Coordinate the retention of the records

- Coordinate calibration activities

- Support lean activities.

- Faciliate Investigations (complaints, failure, etc.

)

- Track and Trend Quality System Data

- Coordinate Internal and Customer Audits

- Coordinate Supplier Quality and Customer Assessments

- Batch Record Release / Approve DHRs

- Report into Management Review.

- Support risk assessment as needed

**Education Degree**:

- High School Diploma or GED

**Required Experience**:

1 year experience preferred with degree in Quality in a regulated industry (i. e.

FDA/ISO 13485)

2.

Associate's degree in related technical field (i. e.

Engineering, Chemistry, Biology) preferred.

**Preferred Experience**:

**Skills**:

1.

Ability to work in a fast-paced environment with strict deadlines

2.

Technical Excellence (Learn) - Analyzes and solves technical problems.

Seeks input from more experienced individuals to improve quality of deliverables.

Generates detailed, high quality technical documentation (i. e. Complaints, CAPAs).

3.

Strategic Thinking

- Gains perspective through experiences and developing new skills.

4.

Execution / Accountability - Provides clear and accurate data regarding product and process measurables.

5.

Judgement / Decision Making - Contributes positively to team decisions and actions

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.

WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services.

STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17, 000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.