Quality Engineer

at  Steris

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:

At Steris AST we are the trusted experts in neutral sterilization offering includes radiation and gas technologies.
We offer electron beam, gamma, X-ray, ethylene oxide and vaporized hydrogen peroxide technologies for the purpose of product sterilization. Whether that product be a single use medical instrument, a hospital environment, cosmetics and toiletries, or food products, we make sure that everything that makes its way to an end user is safe for use or consumption.
We are currently recruiting for a Quality Engineer vacancy. This is an excellent opportunity to join the business at a skilled professional level and help us maintain and build on the excellent quality

REQUIRED EXPERIENCE

Minimum of 3 years professional experience, preferably including regulatory affairs, legal or governmental compliance matters, quality systems, internal auditing, applicable scientific or technical functions and/or healthcare industry experience.
Requires ability to effectively read, write and verbally communicate in English.
Requires to work independently under general guidance and supervision.
Requires effective interpersonal skills as demonstrated through prior experience .
Computer skills and work processing spreadsheet and software capabilities.
Requires above average organizing, analyzing and math skills (practical application od fractions, percentage, ratio, proportions, measurement and basic algebra) to determine organizational, Customer and Regulatory problems and formulate corrective action plan.
Attention to details.
Able to adapt to changing duties and responsibilities.
Able to influence people in the opinions, attitude or judgments, evaluate and decide, to adapt to situations under stress.

Knowledge of:

• 21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
• 21 CFR Part 11 – Electronic Records, Electronic Signatures
• Health Canada, Food and Drug Regulations, Division 2, Part C: Good Manufacturing Practices - Drugs
• ISO 13485: Medical devices – Quality management systems,
• ISO 17025: General requirements for the competence of testing and calibration laboratories
• ISO 9001 Current Certified Version, Quality Management Systems – Requirements
• Volume 4 Good Manufacturing Practice (GMP) Guidelines – EU GMP
• MHLW Ministerial Ordinance No. 169, 2004 of the Japanese Pharmaceutical Affairs Law (PAL).

Preferably:

• ISO 11135 – Sterilization of healthcare products – Ethylene oxide
• ISO 11137 – Sterilization of healthcare products - Radiation

STERIS PLC PROVIDES EMPLOYMENT AND ADVANCEMENT OPPORTUNITIES WITHOUT REGARD TO AGE, DISABILITY, GENDER REASSIGNMENT, MARRIAGE OR CIVIL PARTNERSHIP, PREGNANCY AND MATERNITY, RACE, RELIGION/BELIEF, SEX (GENDER), SEXUAL ORIENTATION OR ANY OTHER LEGALLY PROTECTED CHARACTERISTIC AS DEFINED BY EMPLOYMENT LAW. THE COMPANY BASES ALL EMPLOYMENT DECISIONS ON MERIT, QUALIFICATIONS, SKILLS, AND ABILITIES WITH THE INTENTION THAT THE BEST CANDIDATE IS SELECTED FOR EACH POSITION

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

Please refer the Job description for details